Jack Stevens was diagnosed with juvenile myelomonocytic leukaemia and underwent stem cell treatment but has sadly lost his battle as his father's former clubs pay tribute

The young son of former England footballer Gary Stevens has died tragically aged four.

Stevens son Jack was diagnosed with a rare form of blood cancer.

Just a year ago his family were hopeful of a recovery after Jack underwent a stem cell transplant following his diagnosis with juvenile myelomonocytic leukaemia.

The stem cells Jack received from older brother Oliver had engrafted, meaning they had entered Jacks bone marrow, enabling him to produce his own white blood cells.

The transplant procedure was brought forward after Jack responded to two rounds of preparatory chemotherapy, negating an original plan for five cycles of treatment.

He was discharged to a nearby apartment and during the week lived with mum Louise.

Stevens a brilliant right-back in Howard Kendalls magical mid-1980s Everton team and the couples other sons, Oliver and Josh, would join Jack and Louise at weekends.

This morning Everton said: "Everyone at Everton is deeply saddened to learn that Gary Stevens four-year-old son, Jack, has passed away following his courageous battle with leukaemia.

"Our thoughts are with Gary and his family at this incredibly sad time."

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Stevens, 59, began his football career with Everton, representing the Toffees for six seasons and making over 200 appearances between 1982-1988.

He then transferred to Glasgow Rangers where he played a part in their treble-winning season in 1993.

After another six-year stint, he returned to Merseyside to finish his career plying his trade for Tranmere Rovers.

Stevens earned 46 caps for England during his playing days before moving into physiotherapy after his retirement.

Tranmere shared Everton's post and issued their own touching message, which read: "The thoughts of everyone at Tranmere Rovers are with Gary Stevens and his family at this sad time."

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Former England and Everton footballer Gary Stevens' son tragically dies aged four - Mirror.co.uk

Bone Marrow Stem Cells Comments Off on Former England and Everton footballer Gary Stevens’ son tragically dies aged four – Mirror.co.uk | November 22nd, 2021

PRC Clinical to Provide Start-up CRO Services for BRTX-100 Phase 2 Clinical Trial

MELVILLE, N.Y., Nov. 19, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company" or BioRestorative) (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today announced that it has entered into a letter of intent with PRC Clinical, a CRO specializing in clinical trial management, with regard to PRC Clinical providing startup clinical project management activities for the Companys BRTX-100 Phase 2 clinical trial to treat chronic lumbar disc disease.

We are pleasedto announce that we have entered into a letter of intent for PRC Clinical to provide startup activities for our Phase 2 study. PRC has extensive experience and expertise in managing clinical studies in the stem cell and regenerative medicine space. They also have theexperienced and professionalnetwork of clinicians and study sites streamlining patient enrollment, site monitoring and management. Additionally, we have been working with and familiarizing ourselves with PRCs team and capabilities since 2019. We are thrilled to finally be in a position to begin the process of validating our technology through the FDA process, while keeping shareholders updated along the regulatory pathway, said Lance Alstodt, CEO of BioRestorative.

PRC Clinical has provided specialty CRO services for nearly 20 years. Their innovative approach to executing studies for biotech and pharmaceutical companies combines high-touch human elements and cutting-edge technology with extensive experience and deep therapeutic knowledge. PRC Clinical is an all inclusive CRO and has specialized expertise across regenerative medicine, CNS, ophthalmology, pulmonary and COVID-19, rare and orphan disease and more complex indications.

PRC Clinical is pleased to begin start-up CRO activities for BRTX-100. We look forward to being able to bring our stem cell experience to this trial. We are committed to supporting BioRestoratives development of BRTX-100 and its clinical application, said Curtis Head, CEO of PRC Clinical.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:

Email: ir@biorestorative.com

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BioRestorative Therapies Enters into Letter of Intent with PRC Clinical - GlobeNewswire

Bone Marrow Stem Cells Comments Off on BioRestorative Therapies Enters into Letter of Intent with PRC Clinical – GlobeNewswire | November 22nd, 2021

November 19, 2021 Stem cell therapy helped to reduce the number of heart attacks, strokes and death among people with chronic, high-risk, NYHA class II or III heart failure with reduced ejection fraction (HFrEF), especially among those who have higher levels of inflammation, yet hospitalization was not reduced, according to late-breaking research presented at the American Heart Associations Scientific Sessions 2021.

Heart failure is a condition when the heart is unable to adequately pump blood to meet the bodys need for oxygen and nutrients. In heart failure with reduced ejection fraction (HFrEF), the heart muscle enlarges and weakens, resulting in a decrease in pumping ability and fluid buildup in the bodys tissues. Inflammation plays a significant role in the progression of heart failure over time.

This study set out to examine the effects of using stem cells (mesenchymal precursor cells) injected into the heart to target inflammation and treat chronic heart failure. Researchers hypothesized that a single injection of stem cells from healthy adult donors in addition to guideline-directed medical therapy (GDMT) for heart failure would affect the number of times participants were hospitalized for heart failure events and reduce heart attacks, strokes, and/or death.

Cell therapy has the potential to change how we treat heart failure, said Emerson C. Perin, M.D., Ph.D., the studys lead author, the director of the Center for Clinical Research and medical director of the Texas Heart Institute in Houston. This study addresses the inflammatory aspects of heart failure, which go mostly untreated, despite significant pharmaceutical and device therapy development. Our findings indicate stem cell therapy may be considered for use in addition to standard guideline therapies.

The Randomized Trial of Targeted Transendocardial Delivery of Mesenchymal Precursor Cells in High-Risk Chronic Heart Failure Patients with Reduced Ejection Fraction study also called the DREAM-HF trial, is the largest stem cell therapy study to date among people with heart failure. In this multi-center, randomized, sham-controlled, double-blind trial, researchers enrolled 537 participants (average age 63, 20% female) with heart failure and reduced ejection fraction, which is when the left side of the heart, its main pumping chamber, is significantly weakened.

Heart failure was defined using the New York Heart Association (NYHA) functional classification system. This classification system places patients in one of four categories based on how much they are limited during physical activity. Class I heart failure means no limitation of physical activity, with class IV heart failure meaning an inability to have any physical activity without discomfort.

Participants were randomly divided into two groups: 261 adults received an injection of 150 million mesenchymal precursor cells, commonly known as stem cells, directly into the heart using a catheter. The remaining 276 adults received a scripted, or sham, procedure. Healthy adult donors provided the mesenchymal precursor cells.

The study participants were discharged from the hospital the day after the procedure, and researchers followed these participants for an average of 30 months. The studys focus was to examine if the stem cell treatment affected the likelihood of participants returning to the hospital for treatment of worsening heart failure. They also tracked whether participants had a heart attack or stroke, or died, and measured levels of high-sensitivity C-reactive protein (CRP), a measure in the blood indicating inflammation.

While researchers did not see a decrease in hospitalizations due to the stem cell treatment, they did notice several other significant results. The findings include:

We were impressed to learn that stem cell treatment effects were additive to current standard heart failure treatments, Perin said. For the first time, the known anti-inflammatory mechanism of action of these cells may be linked to a cause-and-effect benefit in heart failure. The stem cells acted locally in the heart, and they also helped in blood vessels throughout the body.

Perin and colleagues believe further research is needed to better understand how these stem cells may affect the course of progression of heart failure and how these therapies may be directed to the patient groups that could see the most benefits.

Limitations to the research include the selection of endpoints commonly used in heart failure studies. The studys results suggest that traditional endpoints associated with recurrent heart failure hospitalization do not fully reveal the benefits or mechanisms of these stem cells on heart attack, stroke and death in patients with chronic heart failure.

Co-authors are Barry H. Greenberg, M.D.; Kenneth M. Borow, M.D.; Timothy D. Henry II, M.D.; Farrell O. Mendelsohn, M.D.; Les R. Miller, M.D.; Elizabeth Swiggum, M.D.; Eric D. Adler, M.D.; Christopher A. James, P.A.; and Silviu Itescu, M.D. Authors disclosures are listed in the abstract.

The study was funded by Mesoblast Inc.

https://www.dicardiology.com/article/late-breaking-science-presentations-aha-2021-meeting

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Stem Cell Therapy for Heart Failure Reduced Major Cardiac Events and Death - Diagnostic and Interventional Cardiology

Cardiac Stem Cells Comments Off on Stem Cell Therapy for Heart Failure Reduced Major Cardiac Events and Death – Diagnostic and Interventional Cardiology | November 22nd, 2021

DUBLIN--(BUSINESS WIRE)--The "Induced Pluripotent Stem Cell (iPSC) Market Share, Size, Trends, Industry Analysis Report By Application (Manufacturing, Academic Research, Drug Development & Discovery, Toxicity Screening, Regenerative Medicine); By Derived Cell; By Region, Segment & Forecast, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.

The global Induced Pluripotent Stem Cell (iPSC) market size is expected to reach $2,893.3 million by 2028

The ability to model human diseases in vitro as well as high-throughput screening has greatly propelled market growth. Companies have effectively overcome market hurdles faced in the recent past such as proper culturing and differentiation of derived cells at a commercial scale and have developed state-of-the-art manufacturing processes that can achieve scalability and can achieve stringent quality parameters. Such trends are propelling the overall industry growth.

Companies have also developed advanced platforms for Induced pluripotent stem cells that guarantee close connection with a host of in-house technologies that are useful in the proper definition of disease signatures as well as relationships between genetic mutations as well as that properly describe perturbation of specific molecular pathways. This has resulted in the creation of human translational models that are aiding better target identification of diseases that have high unmet medical needs.

Many companies have developed transfection kits, reprogramming vectors, differentiation media, live staining kits, immunocytochemistry, among others to aid the smooth workflow of iPSC production.

However, it has been observed in the recent past that the demand for cells for screening and other purposes is significant and that there are significant challenges that pose a significant hurdle in large-scale iPSC production and differentiation.

Heavy investment in R&D activities pertaining to the development and optimization of iPSC reprogramming process in order to achieve sufficient production is a key industry trend. In the recent past, companies focused more on hepatic, cardiac, pancreatic cells, among others.

However, with the advent of a number of new participants as well as advancements and breakthroughs achieved, it is anticipated that the application portfolio will further increase in the near future.

Industry participants operating in the industry are:

Key Topics Covered:

1. Introduction

2. Executive Summary

3. Research Methodology

4. iPSC Market Insights

4.1. iPSC - Industry Snapshot

4.2. iPSC Market Dynamics

4.2.1. Drivers and Opportunities

4.2.1.1. Increasing demand for body reconstruction procedures and tissue engineering

4.2.1.2. Rising Investments across the globe

4.2.2. Restraints and Challenges

4.2.2.1. Scalability Issues

4.3. Porter's Five Forces Analysis

4.4. PESTLE Analysis

4.5. iPSC Market Industry trends

4.6. COVID-19 Impact Analysis

5. Global iPSC Market, by Derived Cell

5.1. Key Findings

5.2. Introduction

5.3. Hepatocytes

5.4. Fibroblasts

5.5. Amniotic Cells

5.6. Cardiomyocytes

6. Global iPSC Market, by Application

6.1. Key Findings

6.2. Introduction

6.2.1. Global iPSC Market, by Application, 2017 - 2028 (USD Million)

6.3. Manufacturing

6.4. Academic Research

6.5. Drug Development & Discovery

6.6. Toxicity Screening

6.7. Regenerative Medicine

7. Global iPSC Market, by Geography

7.1. Key findings

7.2. Introduction

7.2.1. iPSC Market Assessment, By Geography, 2017 - 2028 (USD Million)

8. Competitive Landscape

8.1. Expansion and Acquisition Analysis

8.1.1. Expansion

8.1.2. Acquisitions

8.2. Partnerships/Collaborations/Agreements/Exhibitions

9. Company Profiles

9.1. Company Overview

9.2. Financial Performance

9.3. Product Benchmarking

9.4. Recent Development

For more information about this report visit https://www.researchandmarkets.com/r/ykewbe

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Global Induced Pluripotent Stem Cell (iPSC) Market Report 2021-2028 - Increasing Demand for Body Reconstruction Procedures and Tissue Engineering -...

Cardiac Stem Cells Comments Off on Global Induced Pluripotent Stem Cell (iPSC) Market Report 2021-2028 – Increasing Demand for Body Reconstruction Procedures and Tissue Engineering -… | November 22nd, 2021

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. The approval is based on data from the pivotal Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) compared to placebo. Median DFS has not been reached for either group.

Despite decades of research, limited adjuvant treatment options have been available for earlier-stage renal cell carcinoma patients who are often at risk for recurrence. In KEYNOTE-564, pembrolizumab reduced the risk of disease recurrence or death by 32%, providing a promising new treatment option for certain patients at intermediate-high or high risk of recurrence, said Dr. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and professor of medicine, Harvard Medical School. With this FDA approval, pembrolizumab may address a critical unmet treatment need and has the potential to become a new standard of care in the adjuvant setting for appropriately selected patients.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

KEYTRUDA is foundational for the treatment of patients with certain advanced cancers, and this approval marks the fourth indication for KEYTRUDA in earlier stages of cancer, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. KEYTRUDA is now the first immunotherapy approved for the adjuvant treatment of certain patients with renal cell carcinoma. This milestone is a testament to our commitment to help more people living with cancer.

In RCC, Merck has a broad clinical development program exploring KEYTRUDA, as monotherapy or in combination, as well as other investigational products across multiple settings and stages of RCC, including adjuvant and advanced or metastatic disease.

Data Supporting the Approval

KEYTRUDA demonstrated a statistically significant improvement in DFS in patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions compared with placebo (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010). The trial will continue to assess overall survival (OS) as a secondary outcome measure.

In KEYNOTE-564, the median duration of exposure to KEYTRUDA was 11.1 months (range, 1 day to 14.3 months). Serious adverse reactions occurred in 20% of these patients receiving KEYTRUDA. Serious adverse reactions (1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% of those treated with KEYTRUDA, including one case of pneumonia. Adverse reactions leading to discontinuation occurred in 21% of patients receiving KEYTRUDA; the most common (1%) were increased alanine aminotransferase (1.6%), colitis and adrenal insufficiency (1% each). The most common adverse reactions (all grades 20%) in the KEYTRUDA arm were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%) and hypothyroidism (21%).

About KEYNOTE-564

KEYNOTE-564 (ClinicalTrials.gov, NCT03142334) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating KEYTRUDA as adjuvant therapy for RCC in 994 patients with intermediate-high or high risk of recurrence of RCC or M1 no evidence of disease (NED). Patients must have undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion[s] in M1 NED participants) with negative surgical margins for at least four weeks prior to the time of screening. Patients were excluded from the trial if they had received prior systemic therapy for advanced RCC. Patients with active autoimmune disease or a medical condition that required immunosuppression were also ineligible. The major efficacy outcome measure was investigator-assessed DFS, defined as time to recurrence, metastasis or death. An additional outcome measure was OS. Patients were randomized (1:1) to receive KEYTRUDA 200 mg administered intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity.

About Renal Cell Carcinoma (RCC)

Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCCs. Renal cell carcinoma is about twice as common in men than in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. In the U.S., it is estimated there will be more than 76,000 new cases of kidney cancer diagnosed and almost 14,000 deaths from the disease in 2021.

About Mercks Early-Stage Cancer Clinical Program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS 1)] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):

Non-muscle Invasive Bladder Cancer

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Cancer

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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FDA Approves Merck's KEYTRUDA (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery - Business...

Cardiac Stem Cells Comments Off on FDA Approves Merck’s KEYTRUDA (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery – Business… | November 22nd, 2021

Stem cell therapy holds immense promise for the treatment of patients with diabetes mellitus. Research on the ability of human embryonic stem cells to differentiate into islet cells has defined the developmental stages and transcription factors involved in this process. However, the clinical applications of human embryonic stem cells are limited by ethical concerns, as well as the potential for teratoma formation. As a consequence, alternative forms of stem cell therapies, such as induced pluripotent stem cells, umbilical cord stem cells and bone marrow-derived mesenchymal stem cells, have become an area of intense study. Recent advances in stem cell therapy may turn this into a realistic treatment for diabetes in the near future.

Keywords: Embryonic stem cell, induced pluripotent stem cell, mesenchymal stem cell, diabetes

This lecture is based on a recent review.[1]

The increasing burden of diabetes worldwide is well-known, and the effects on health care costs and in human suffering, morbidity, and mortality will be primarily felt in the developing nations including India, China, and countries in Africa. New drugs are being developed at a rapid pace, and the last few years have seen several new classes of compounds for the treatment of diabetes e.g. glucagon-like peptide (GLP-1) mimetics, dipeptidyl-peptidase-4 (DPP-4) inhibitors, sodium glucose transporter-2 (SGLT2) inhibitors. New surgical treatments have also become increasingly available and advocated as effective therapies for diabetes. Gastric restriction surgery, gastric bypass surgery, simultaneous pancreas-kidney transplantation, pancreatic and islet transplantation have all been introduced in recent years. To avoid the trauma of a major operation, there have been many studies on the transplantation of isolated islets removed from a cadaveric pancreas. There was encouragement from the Edmonton protocol described by Shapiro and colleagues in the New England Journal in 2000. The islets were injected into the portal vein and patients, especially those suffering from dangerous, hypoglycemic unawareness, were treated before they had developed severe complications of diabetes, especially renal complications. While the early results were promising, with some 70% of the patients requiring no insulin injections after two years, at five years, most of these patients had deteriorated and required insulin supplements, despite some having received more than one transplant of islets. In the more recent series of patients, the Edmonton group has reported better long-term results with the use of the monoclonal anti-lymphocyte antibody, Campath 1H given as an induction agent, 45% of patients being insulin-independent at five years, and 75% had detectable C-peptide.

However, cadavaric pancreata and islets compete for the same source and are limited in number, and so, neither treatment could readily be offered to the vast majority of diabetic patients. Some have attempted to use an alternative source, for example, encapsulated islets from neonatal or adult pigs. This is still very experimental and will be a far away alternative with many technical and possibly ethical obstacles to overcome.

More recently, with the successes in the development of pluripotent adult stem cells (from Yamanaka, awarded the 2012 Nobel prize for medicine for developing induced pluripotent stem cells iPSCs), new approaches to seek a methods that may be more accessible and available have been attempted. Much hope was derived initially from embryonic stem cell (ESC) research, since these cells can be persuaded to multiply and develop into any tissue, but the process was expensive, and the problem of teratoma formation from these stem cells proved extremely difficult to overcome. Many of the important factors related to fetal development are not understood and cannot be reproduced. However, some progress has been made, and (occasionally) cells been persuaded to secrete insulin, but so far, there have been very minimal therapeutic application.

Scientists are now aware that to persuade a cell to produce insulin is only one step in what may be a long and difficult journey. Islets cells are highly specialized to have not only a basal release of insulin but also to respond rapidly to changes in blood glucose concentration. With insulin, the process and regulation of switching off secretion is as important as the switching on secretion.

A variety of approaches has been made with different starting points. The stem cell reproduces itself and can then also divide asymmetrically and form another cell type: This is known as differentiation. Although initially they were thought to be available only from embryos, non-embryonic stem cells can now be obtained without too much difficulty from neonatal tissue, umbilical cord, and also from a variety of adult tissues including bone marrow, skin, and fat. These stem cells can be expanded and made to differentiate, but their repertoire is restricted compared with embryonic stem cells: oligo- or pluri- as opposed to toti-potent embryonic stem cells. Even more, recently, there has been much interest in the process of direct cell trans-differentiation, in which a committed and fully differentiated cell, for example a liver cell, is changed directly to another cell type, for example an islet beta-cell, without induction of de-differentiation back to a stem cell stage.

Yamanaka, in 2006, was able to produce pluripotent stem cells from mouse neonatal and adult fibroblast cultures by adding a cocktail of four defined factors.[2] This led to a series of other studies developing the process, which was shown to be repeatable with human tissue as well as laboratory mice. The use of iPS cells avoided the ethical constraints of using human embryos, but there have been other problems and obstacles still. There have been emerging reports of iPS cells becoming antigenic to an autologous or isologous host, and the cells can accumulate DNA abnormalities and even retain epigenetic memory of the cell type of origin and thus have a tendency to revert back. Like embryonic stem cells, iPS cells can form teratoma, especially if differentiation is not complete.

Despite this, there has been very little success in directing differentiation of iPSCs to form islet beta-cells in sufficient quantity that will secrete and stop secretion in response to changes in blood glucose levels.

Another approach that has been tried is to combine gene therapy with stem cells. Some progress has been made in trying to express the desired insulin gene in more primitive undifferentiated cells by coaxing stem cells with differentiation factors in vitro and then by direct gene transfection using plasmids or a viral vector. We, and others, have used a human insulin gene construct and introduced ex vivo or in vivo into cells by direct electroporation (in ex vivo cells obviously) or by viral vectors. The adenovirus, adeno-associated virus, and various retro viruses have been most studied, especially the Lentivirus. However, any type of genetic engineering raises fears not only of infection from the virus but also of the unmasking of onco-genes, leading to malignancy, and there are strict regulations how to proceed to avoid these risks.

We have been interested in umbilical cord stem cells and in mesenchymal stem cells as targets for combined stem cell and gene therapy. These cells can be obtained in a reasonably easy and reproducible manner from otherwise discarded umbilical cord, or readily accessible bone marrow, selecting out the cells using various standard techniques. Fat, amnion, and umbilical cord blood are also sources, from which mesnechymal stem cells can be derived. After a proliferative phase, the cells take up an appearance similar to a carpet of fibroblasts, which can differentiate into bone, cartilage, or fat cells. Although mesenchymal stem cells from the various sources mentioned may look similar, their differentiation potentials are idiosyncratic and differ, which makes it inappropriate and difficult to think of them as a uniform source of target cells. Neonatal amnion cells and umbilical cord cells have low immunogenicity and do not express HLA class II antigens. They also secrete factors that inhibit immune reactions, for example, soluble HLA-G. Although immunogenicity is reduced significantly, they are still not autologous and, therefore, there remains a risk for allograft rejection. They have the advantage that they could be multiplied, frozen, and banked in large numbers and could be used in patients already needing immunosuppressive agents, for examples those having renal transplants.

In Singapore, our studies of umbilical cord-derived amnion cells have shown some success in having expression of insulin and glucagon genes, but little or no secretion of insulin in vitro. Together with insulin gene transfection in vitro, after peritoneal transplantation into sterptozotocin-induced diabetic mice, there was some improvement in glucose levels.[3] Our colleagues in Singapore[4,5] have used another model of autologous hepatocytes from streptozotocin-induced diabetic pigs. These separated hepatocytes were successfully transfected ex-vivo with a human insulin gene construct by electrophoration, and then the cells were injected directly back into the liver parenchyma using multiple separate injections. The pigs were cured of their diabetes for up to nine months - which is a remarkable achievement. As these were autotransplantations, no immunosuppressive drugs were necessary, but the liver cells were obtained from large open surgical biopsies. This necessity of surgical removal of liver tissue would limit its applicability, but nevertheless has been a good proof of concept study. In the context of autoimmune diabetes, the risk of recurrent disease may well persist unless the target of autoimmune attack could be defined and eliminated. In these porcine experiments, the human insulin gene with a glucose sensing promoter EGR-1 was used. There was no virus involved, and the plasmid does not integrate. Division of the transfected cell would dilute gene activity, but large numbers of plasmid can be produced cheaply. The same group of workers successfully transfected bone marrow mesenchymal stem cells with the human insulin gene plasmid using the same EGR-1 promoter and electrophoration. This cured diabetic mice after direct intra-hepatic and intra-peritoneal injection.

Finally, there should be caution in interpreting the results of these and other reports of cell and gene therapy for diabetes. In gene transfection and/or transplantation of insulin-producing cells or clusters in the diabetic rodent, there have been many reports in the literature, but only a few of these claims have been reproduced in independent laboratories. We have suggested the need to satisfy The Seven Pillars of Credibility as essential criteria in the evaluation of claims of success in the use of stem cell and/or gene therapy for diabetes.[1]

Cure of hyperglycemia

Response to glucose tolerance test

Evidence of appropriate C-peptide secretion

Weight gain

Prompt return of diabetes when the transfecting gene and/or insulin producing cells are removed

No islet regeneration of stereptozotocin-treated animals and no re-generation of pancreas in pancreatectomized animals

Presence of insulin storage granules in the treated cells

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Stem cell therapy for diabetes - PubMed Central (PMC)

IPS Cell Therapy Comments Off on Stem cell therapy for diabetes – PubMed Central (PMC) | November 22nd, 2021

Passage Of California Stem Cell Proposition Boosts Research

For the last decade and more, Stem Cell research and regenerative medicine have been the rave of the healthcare industry, a delicate area that has seen steady advancements over the last few years.

The promise of regenerative medicine is simple but profound that one day medical experts will be able to diagnose a problem, remove some of our body cells called stem cells and use them to grow a cure for our ailment. Using our body cells will create a highly personalized therapy attuned to our genes and systems.

The terminologies often used in this field of medicine can get a bit fuzzy for the uninitiated, so in this article, I have relied heavily on the insights of Christian Drapeau, a neurophysiologist and stem cell expert.

Drapeau was one of the first voices who discovered and began to speak about stem cells being the bodys repair system in the early 2000s. Since then, he has gone on to discover the first stem cell mobilizer, and his studies and research delivered the proof of concept that the AFA (Aphanizomenon flos-aquae) extract was capable of enhancing repair from muscle injury.

Christian Drapeau is also the founder of Kalyagen, astem cell research-based company, and the manufacturers of Stemregen. This stem cell mobilizer combines some of the most effective stem cell mobilizers Drapeau has discovered to create an effective treatment for varying diseases.

How exactly do stem cell-based treatments work? And how is it delivering on its promise of boosting our abilities to regenerate or self-heal?

Drapeau explains the concept for us;

Stem cells are mother cells or blank cells produced by the bone marrow. As they are released from the bone marrow stem cells can travel to any organ and tissue of the body, where they can transform into cells of that tissue.Stem cells constitute the repair system of the body.

The discovery of this function has led scientists on a long journey to discover how to use stem cells to cure diseases, which are essentially caused by cellular loss. Diseases like Diabetes and age-related degenerative diseases are all associated with the loss of a type of cell or cellular function.

However, what Drapeaus research has unearthed over the last few decades is that there are naturally occurring substances that show a demonstrated ability to induce the release of stem cells from the bone marrow. These stem cells then enter the bloodstream, from where they can travel to sites of cell deficiency or injury in the body to aid healing and regeneration. This process is referred to as Endogenous Stem Cell Mobilization (ESCM).

Stemregen is our most potent creation so far, explains Drapeau, and it has shown excellent results with the treatment of problems in the endocrine system, muscles, kidneys, respiratory systems, and even with issues of erectile dysfunction.

Despite the stunning advancements that have been made so far, a concern that both Drapeau and I share is how this innovation can be merged with another exciting innovation; AI.

Is it even a possibility? Drapeau, an AI enthusiast, explains that AI has already been a life-saver in stem cell research and has even more potential.

On closer observation, there are a few areas in which AI has greatly benefited stem cell research and regenerative medicine.

One obstacle that scientists have consistently faced with delivering the full promise of regenerative medicine is the complexity of the available data.Cells are so different from each other that scientists can struggle with predicting what the cells will do in any given therapeutic scenario. Scientists are faced with millions of ways that medical therapy could go wrong.

Most AI experts believe that in almost any field, AI can provide a solution whenever there is a problem with data analysis and predictive analysis.

Carl Simon, a biologist at the National Institute of Standards and Technology (NIST) and Nicholas Schaub recentlytested this hypothesiswhen they applied Deep Neural Networks (DNN), an AI program to the data they had collected in their experiments on eye cells. Their research revolved around causes and solutions for age-related eye degeneration. The results were stunning; the AI made only one incorrect prediction about cell changes out of 36 predictions it was asked to make.

Their program learned how to predict cell function in different scenarios and settings from annotated images of cells. It soon could rapidly analyze images of the lab-grown eye tissues to classify the tissues as good or bad. This discovery has raised optimism in the stem cell research space.

Drapeau explains why this is so exciting;

When we talk about stem cells in general, we say stem cells as if they were all one thing, but there are many different types of stem cells.For example, hair follicle and dental pulp stem cells contain neuronal markers and can easily transform into neurons to repair the brain. Furthermore, the tissue undergoing repair must signal to attract stem cells and must secrete compounds to stimulate stem cell function. A complex analysis of the tissue that needs repair and the conditions of that tissue using AI, in any specific individual, will help select the right type of stem cells and the best cells in that stem cell population, along with the accompanying treatment to optimize stem cell-based tissue repair.

Christian Drapeau

Ina study published in Februaryof this year inStem Cells, researchers from Tokyo Medical and Dental University (TMDU) reported that their AI system, called DeepACT, had successfully identified healthy, productive skin stem cells with the same accuracy that a human could. This discovery further strengthens Drapeaus argument on the potentials of AI in this field.

This experiment owes its success to AIs machine learning capabilities, but it is expected that Deep Learning can be beneficially introduced into regenerative medicine.There are many futuristic projections for these possibilities, but many of them are not as far-fetched as they may first seem.

Researchers believe that AI can help fast-track the translation of regenerative medicine into clinical practice; the technology can be used to predict cell behavior in different environments. Therefore, hypothetically, it can be used to simulate the human environment. This means that researchers can gain in-depth information more rapidly.

Perhaps the most daring expectation is the possibility of using AI to pioneer the 3D printing of organs. In a world where organ shortage is a harsh reality, this would certainly come in handy. AI algorithms can be utilized to identify the best materials for artificial organs, understand the anatomic challenges during treatment, and design the organ.

Can stem cells actually be used along with other biological materials to grow functional 3D-printed organs? If this is possible, then pacemakers will soon give way to 3D-printed hearts. A 3D-printedheart valvehas already become a reality in India, making this even more of an imminent possibility.

While all of these possibilities excite Drapeau, he is confident that AIs capabilities with data analysis and prediction, which is already largely in use, would go down as its most beneficial contribution to stem cell research;

It was already shown that stem cells laid on the connective tissue of the heart, the soft skeleton of the heart, can lead the entire formation of a new heart. Stem cells have this enormous regenerative potential. AI can take this to another level by helping establish the conditions in which this type of regeneration can be orchestrated inside the body.But we have to be grateful for what we already have, over the last 20 years, I have studied endogenous stem cell mobilization and today the fact that we have such amazing results with Stemregen is testament that regenerative medicine is already a success.

As AI continues to scale over industry boundaries, we can only sit back and hope it delivers on its full potential promise. Who knows? Perhaps AI really can change the world.

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How The Overlap Between Artificial Intelligence And Stem Cell Research Is Producing Exciting Results - Forbes

Skin Stem Cells Comments Off on How The Overlap Between Artificial Intelligence And Stem Cell Research Is Producing Exciting Results – Forbes | November 22nd, 2021

Dr Pengyi Yang uses computational expertise to build virtual cells.

DrPengyiYanghasreceived one of two annual $55,000 Metcalf Prizes from the National Stem Cell Foundation of Australia inrecognition of his leadership in the field.

DrYangholds a joint position with the University of SydneySchool of Mathematics & Statistics, theCharles Perkins Centreand theChildren's MedicalResearch Institute. His work aims toremove much of the guesswork from stemcell science and eventually stemcell medicine.

Todays stem cell treatmentshave beenthe product of trial anderror, DrYang said.

My virtual stem cell will allow us to understand whats happening inside a single stem cell that makes it decide what type of cell it will becomesuch as, but not limited to,hair, skin, muscle, nerveorbloodcells.

He is mapping the many, complex influencescontrollingstem cells andthe waythey specialise into different cell types.

Stem cells are amazing because they can produce any kind of cell in the body. Theyre fundamental toregenerative medicine,DrYang said.

But, when theircontrols fail,rogue stem cells can lead to cancer.

Allhumanlifestartsas a single stem cell. It goes on to produce cells that eventually become every type of tissue and organ of the human body. Even in adulthood, stem cellsrepairandreplacetissue all the time.

People are excited about the potential of stem cell medicine, but thereality is extremely complicated. Thousands of genes, complex gene networks, environmental factors, and an individuals own health are all involved in pushing stem cells to become specific cell types,DrYang said.

DrYang, a computerscientist turned stem cell researcher, uses computational science and statistics to understand how stem cells function at a fundamental level work that will be useful forthe entire stem cell field ofresearch.

We need a computermodel to bring all of these influences togetherso we can identify the specific gene networks that drive the stem cells towards each cell type,he said.

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Dr Pengyi Yang wins National Stem Cell Foundation Metcalf Prize - News - The University of Sydney

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Sponsored Article

Although stem cells are known to work wonders, there is still a lot of misunderstanding about what they are, what they do, and how they work.

The good news is that StemCells21 can clear everything up for you. SC21 produces all of its cellular medications in-house, and all of its treatments are performed at its cutting-edge medical centre in Bangkok. Its a one-stop shop that adheres to high-quality standards.

This company will be on display at the Thailand International Boat Show, which will be hosted at Royal Phuket Marina from January 6 to 9 next year. Staff from StemCells21 will be on hand to walk you through the producers, pricing, and techniques.

StemCells21s laboratory is a full-scale culture & analysis laboratory specialising in the production & treatment of Mesenchymal Stem Cells (StemCells21), and Natural Killer Cells (ImmuneCells21). It has also launched a new generation of regenerative medicine called Pluripotent Stem Cells (iPSC21), which hold great potential for impacting chronic diseases in the quest for anti-ageing.

The lab has seven scientists & stem cell researchers, a couple of who have worked with Professor Shinya Yamanaka, who was awarded the Nobel Prize in Physiology or Medicine in 2012 for the discovery that mature cells can be reprogrammed to become pluripotent (iPS cells).

Photo Via: Stemcells 21

Before StemCells21 was created, Managing Director Paul Collier and co-founder Sergei Dmitrievs experienced the power of stem cells either first hand or through the treatment of someone close to them. They knew that stem cells could deliver positive health results, and also knew stem cell treatmentsand the clinics that administered themhad room for improvement.

After deep laboratory investigation, they came to see that most clinics utilised relatively low-quality stem cells and incomplete treatments. While these clinics could deliver a certain level of positive results, they were only scratching the surface of the promise that stem cell treatments could deliver.

Furthermore, the clinics themselves frequently provided a less-than-ideal patient experience. Clinics were generally hectic, unprofessional, and unwelcoming. Patients were often administered a single treatment and sent on their way, unsure if they had experienced an efficacious treatment or if they had travelled and paid for nothing.

StemCells21 was created to offer superior results and give you a welcoming experience. It was set up to provide the global community with access to treatments that few people are aware of, and to offer health benefits that are superior to what most people ever imagined were possible.

The SC21 complex in Bangkok houses the StemCells21, ImmuneCells21, and IPS21 laboratories, as well as the premium 5* IntelliHealth+ (IH+) Clinic.

IntelliHealth+ is a state-of-the-art medical centre licensed by the Thai medical authorities. The luxurious design, efficient workflow layouts, and modern treatments make it the ideal choice for customers seeking a premium level of healthcare in 5* settings.

The centre treats patients from all over the world and has staff who speak fluent English, Arabic, Chinese, Russian, Thai and Spanish.

Furthermore, SC21s come from all corners of the globe for these cutting edge treatments. Many VIPs travel to the clinic including presidents, prime ministers, sports stars, football managers, bank owners and heads of major corporations, many of whom return every six to twelve months and have been doing so for years.

Recently, SC21 treated a ten-year-old British boy who had Ewing sarcoma develop in his arm, which then spread to other areas. He had tried every treatment option in the UK. His trip and treatment were sponsored by UK football teams and the public. Since he started treatment hes put on weight, hes vibrant, and his demeanour has totally changed. Various tests and scans have shown he is responding very well to the immunotherapy course and will perform another round in a few months time.

SC21 focuses on three main areas: anti-ageing and longevity; orthopaedic and muscular-skeletal issues (knee, hip, back & shoulder); and chronic diseases (diabetes, liver cirrhosis, lung, respiratory, hearing & vision disorders). Aside from that, the clinic can also help with chronic fatigue and burn-out syndrome.

Outpatient services for anti-ageing, immunotherapy and regenerative medicine are available at the centre. The anti-ageing clinic has a cutting-edge approach to skin rejuvenation, dermatology, detoxification, and wellbeing. A youthful appearance, more energy, improved mental capacity and mobility, reduced aches and pains, and a stronger immune system are among the benefits.

Photo Via: Stemcells 21

The high level of traditional medicine and the unique protocols designed by the IH+ teams give patients real therapeutic benefits and longevity.

According to Paul Collier, a client typically receives two sessions of stem cell injections during a treatment intravenous for systemic and local to the target and is required to stay in Bangkok for two days following their procedure to monitor any complications that may arise. Then theyre given a two-month take-home kit that comprises self-administered injections (similar to insulin) that target specific growth factors in organs or tissues that need to be repaired. These can also be taken orally, but they are less effective.

He goes on to say that stem cells are the foundation of the human body. They split over and over to produce humans from an embryo at the start of our lives. They restore cells in your blood, bone, skin, and organs throughout your life to keep you alive and functioning. Stem cells have two distinct properties that distinguish them from other types of cells in our bodies.

First, they can self-renew (mitosis), which is a stage of the cell cycle in which replicated chromosomes are divided into two new nuclei. As a result, identical duplicated cells are produced.

Secondly, they have the ability to differentiate into specialized cells such as cartilage, heart cells, liver cells, and neurons. No other cell in the body has the natural ability to generate new cell types.

Mesenchymal Stem Cells (MSCs) are at the core of StemCells21s regenerative programs. They are multipotent stem cells derived from various adult and fetal tissues. A large number of studies have shown the beneficial effects of MSC-based therapies to treat different pathologies, including neurological disorders, cardiac ischemia, diabetes, and bone and cartilage diseases.

StemCells21 also has arthritis treatment, which reduces inflammation & joint pain, increases cartilage growth, improves mobility & joint stability and lessens dependence on medication. The clinics degenerative spine treatments help discs regenerate and stabilize the spine.

On top of that, it provides lung & liver disease treatment as well as treatments for autism, cerebral palsy, diabetes, motor neuron disease, multiple sclerosis and immune disorders.

Theres even eye treatment, which reduces blurred vision & field of vision defects, improves night vision & enhances colour texture.

Photo Via: Stemcells 21

SC21 can even help with certain types of cancer by taking a clients blood and growing their natural killer cells (immunotherapy) over a 21-day period. Through various stimuli, their cytotoxicity is increased which kills cancer and virally-affected cells.

Paul says stem cell therapy should be looked at before undergoing any kind of invasive surgery. The type of medicine should certainly be an intervention before surgery. If you are looking at knee replacement, why not consider an injection of a biologic that would only take a couple of days and has the potential to remodel the cartilage, because once you perform surgery there is no going back.

SC21 also produces a wide range of stem-cell extract-based cosmetics and nutritional supplements, which are available at their medical centres and online under the brand SC21 Biotech.

The Thailand International Boat Show will feature Paul Collier and his team. Theyll be able to answer any of your questions about the cost, procedure, and treatment. On top of that, they will also assist you in educating yourself and managing your expectations so that you do not expect more than stem cell therapy can provide. If you want to get treatment, they will also provide you with a complete report on all treatments. SC21 is fully compliant with international regulations and guidelines.

http://www.stemcells21.com http://www.intellihealthplus.com

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SC21- 21st century cellular medicines specialists - The Thaiger

Skin Stem Cells Comments Off on SC21- 21st century cellular medicines specialists – The Thaiger | November 22nd, 2021

According to a new market report published by Transparency Market Research Scar Treatment Market (By Scar Type: Atrophic & Acne Scars, Hypertrophic Scars and Keloids, Contracture Scars, Others (Stretch Marks), By treatment type (Topical Products (Creams, Gels, Silicone Sheets, Others (Sprays, Oils, etc.)), Laser Treatment (CO2 Lasers, Pulsed Dye Laser, Excimer Laser), Injectables, Others, By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) Global Industry Analysis, Size, Share, Growth, Trends & Forecast, 2019 2027. According to the report, the global scar treatment market was valued at US$ 15,805.4 Mn in 2019 and is projected to reach US$ 32,141.8 Mn by 2027, expanding at a high CAGR of 8.3% from 2019 to 2027. Increase in number of people suffering from skin problems across the world is anticipated to fuel the global scar treatment market during the forecast period.

Overview

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Increase in Incidence of Atrophic & Acne Scars and Hypertrophic Scars and Keloids to Boost Market

Topical Products Segment Dominates the Market

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Hospital Pharmacies Segment to Expand at Fastest CAGR

North America to be Highly Lucrative Market for Scar Treatment

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Trend of Strategic Alliance with Local Companies to Strengthen Distribution Network and Expand Geographic Presence

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Stem Cells Market: A significant rise in the number of clinical application of stem cells and the advent of new treatments for chronic diseases are estimated to enhance the growth of the global stem cells market in the next few years. In addition to this, the rising investment by public as well as private organizations for research activities are likely to supplement the overall market growth in the near future.

D-dimer Testing Market: The concept of automation has extended to D-dimer testing as well, which is less labor intensive, rapid, and easy-to-use. Combination of various technologies has increased the yield and productivity. This technological revolution in D-dimer testing is expected to drive the market from 2017 to 2025.

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Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.

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Scar Treatment Market: The Atrophic & Acne scars segment is projected to account for a dominant share of the market - BioSpace

Skin Stem Cells Comments Off on Scar Treatment Market: The Atrophic & Acne scars segment is projected to account for a dominant share of the market – BioSpace | November 22nd, 2021

As POPSUGAR editors, we independently select and write about stuff we love and think you'll like too. If you buy a product we have recommended, we may receive affiliate commission, which in turn supports our work.

If Know Beauty sounds familiar, it's probably because the brand's founders are Vanessa Hudgens and Madison Beer. It's a skin-care line that examines your skin health holistically by looking at lifestyle factors and genetics. The brand wants its users to stop the haphazard trial and error and think about skin care in a smart yet simple way catering to your own needs. The product line has a gentle approach to treating skin concerns while still incorporating actives. It joins the ever-growing list of celebrity-owned beauty brands, and I was very intrigued to try it out.

Ever since I saw her sing her heart out in the premiere of High School Musical, I became an instant Hudgens fan. I can still belt out "Start of Something New." However, when she opened up about her journey with acne, it made me adore her even more. I dealt with acne as a teen and still do now. As I was scrolling through the site, the Bubbling Oxygen Mask ($22) piqued my interest, plus it was perfect for the drier months. Once I discovered that it was part of Hudgens's routine, I knew I had to test it out. Keep reading for my in-depth review.

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I Tried Know Beauty's Bubble Oxygen Face Mask, and It Was a Fun Way to Boost Hydration - POPSUGAR

Skin Stem Cells Comments Off on I Tried Know Beauty’s Bubble Oxygen Face Mask, and It Was a Fun Way to Boost Hydration – POPSUGAR | November 22nd, 2021

The biomedical field is constantly working to make new medical solutions that can help treat patients with various illnesses and conditions. Today, there are numerous medical solutions used today to help ease medical treatment for patients. These solutions include new medical devices, implants, software used to run medical equipment, and information technology systems.

The following are some of the most popular medical technologies that are used today:

Information technologies are another type of technology used today in medicine. For example, imaging systems let doctors examine patients like never before by allowing them to see inside a persons body without performing surgery first. One famous example of this type of medical solution is 3-D imaging software that uses pictures taken with an X-ray machine to give doctors a model to track health changes over time. Another example includes using information technology systems to control medical equipment or devices through smartphone computer programming or apps.

This type of technology allows doctors to use medical equipment with greater accuracy and helps make their work easier. For example, different types of imaging software help provide more transparent images for radiologists when they read X-rays and MRIs. This helps with making a diagnosis quicker. Thats why most hospitals would prefer to work with Wound Care, a web-based EHR tool. Such tools help record patient vitals and wound assessments to track each patients progress and provide better treatment.

These products can be used as medical solutions for people who want to check their health but dont want to visit a doctors office. Wearable health technologies include everything from smartwatches that measure heart rate and blood pressure functions to fitness trackers that help wearers monitor daily activity levels. Even Google has made its smart contact lenses that can track glucose levels for people with diabetes. However, these devices are designed specifically for individuals suffering from chronic diseases such as arthritis or Parkinsons disease in many cases.

Synthetic biology and genetic engineering tools are a technology used to treat illnesses or conditions that affect organs in the body. For example, if a patient has heart disease, they may need a new heart valve. In this case, doctors can use synthetic biology and genetic engineering tools to create a different kind of heart valve from those typically made from cow tissue. These valves have been tested on animals, and now researchers are testing them on humans as well.

Laboratory-grown organs are another medical solution used to help treat patients who need transplants for certain diseases or conditions that may have caused organ failure. A typical example is how stem cells taken from bone marrow can be turned into blood cells and then used to help treat patients with leukemia. Other types of laboratory-grown organs being tested in clinical trials today include partially functional livers and lungs grown from stem cells.

Medical equipment is another technology doctors can use when treating patients. For example, medical imaging devices like CT scanners and MRI machines help provide images of the bodys internal structures for diagnosis so doctors can see problems most other methods cannot detect. Another type of medical equipment includes surgical robots that can be moved by a computer program to perform surgery on a patient. This reduces the need for an incision since some procedures only require small openings or ones that heal very well without stitches or staples closing them up afterward.

Stem cells and stem cell therapies are a type of medical solution used to treat patients who have conditions that can be life-threatening or cause other severe complications. For example, patients with leukemia may need transplanted blood cells from healthy donors. In this case, doctors can use stem cells to develop those types of blood cells that will provide the best chance of curing the patients cancer without harming their body.

Other examples include using cord blood stem cells from newborns to make different kinds of healthy blood and immune system cells for older children and adults with certain diseases or using skin or other non-embryonic stem cells to make insulin-producing pancreatic beta cells for people diagnosed with diabetes Type 1.

Overall, biomedical technologies have been beneficial in making it easier for doctors to diagnose and treat their patients. Thanks to these technologies, many patients can live long, healthy lives with their illnesses or conditions under control. As technology continues advancing over time, even more, advanced solutions will come out, which should further help improve patient care. However, the use of new medical solutions must be approved by a doctor before being used on a patient.

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What Are New Medical Solutions That Can Help Treat Patients? - iLounge

Skin Stem Cells Comments Off on What Are New Medical Solutions That Can Help Treat Patients? – iLounge | November 22nd, 2021

This article was originally published here

Sci Rep. 2021 Nov 5;11(1):21722. doi: 10.1038/s41598-021-01071-2.

ABSTRACT

Spinal cord regeneration is limited due to various obstacles and complex pathophysiological events after injury. Combination therapy is one approach that recently garnered attention for spinal cord injury (SCI) recovery. A composite of three-dimensional (3D) collagen hydrogel containing epothilone B (EpoB)-loaded polycaprolactone (PCL) microspheres (2.5 ng/mg, 10 ng/mg, and 40 ng/mg EpoB/PCL) were fabricated and optimized to improve motor neuron (MN) differentiation efficacy of human endometrial stem cells (hEnSCs). The microspheres were characterized using liquid chromatography-mass/mass spectrometry (LC-mas/mas) to assess the drug release and scanning electron microscope (SEM) for morphological assessment. hEnSCs were isolated, then characterized by flow cytometry, and seeded on the optimized 3D composite. Based on cell morphology and proliferation, cross-linked collagen hydrogels with and without 2.5 ng/mg EpoB loaded PCL microspheres were selected as the optimized formulations to compare the effect of EpoB release on MN differentiation. After differentiation, the expression of MN markers was estimated by real-time PCR and immunofluorescence (IF). The collagen hydrogel containing the EpoB group had the highest HB9 and ISL-1 expression and the longest neurite elongation. Providing a 3D permissive environment with EpoB, significantly improves MN-like cell differentiation and maturation of hEnSCs and is a promising approach to replace lost neurons after SCI.

PMID:34741076 | DOI:10.1038/s41598-021-01071-2

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Improving motor neuron-like cell differentiation of hEnSCs by the combination of epothilone B loaded PCL microspheres in optimized 3D collagen...

Spinal Cord Stem Cells Comments Off on Improving motor neuron-like cell differentiation of hEnSCs by the combination of epothilone B loaded PCL microspheres in optimized 3D collagen… | November 8th, 2021

UW Health treats first patient in U.S. with investigational cell therapy for heart disease

Appleton resident Donald Krause became the first patient in the country last week to undergo an investigational cell therapy for a debilitating heart condition called chronic myocardial ischemia (CMI). Krause was treated by Amish Raval, MD, an interventional cardiologist at UW Health, supported by Peiman Hematti, MD, a bone marrow transplantation hematologist at the UW School of Medicine and Public Health.

October 29, 2021SMPH News

Center members Dr. Anita Bhattacharyy and Dr. Su-Chun Zhang, in collaboration with Waisman and the University of Washington-Seattle and Seattle Childrens Hospital, have been awarded an $11 million Transformative Research grant from the National Institutes of Health to create a new approach using stem cells that may reveal how brain development in individuals with Down syndrome differs from typically developing individuals, identify features that will help understand their intellectual disability, and find potential targets for therapy. They will also address questions that remain unanswered about brain development overall.

October 7th, 2021UW News

The U.S. Food and Drug Administration on Tuesday approved StrataGraft, a topical treatment for severe burns made from skin tissue, providing a boost for Madison-based firm Stratatech. Stratatech was founded in 2000 by SCRMC member Lynn Allen-Hoffman, the first female University of Wisconsin-Madison faculty member to start a biotech company.

June 16, 2021The Cap Times

The Food and Drug Administration-approved trial will use a form of transplant that replaces a patients bone marrow with alpha-beta T-cell depleted peripheral blood stem cells from closely matched unrelated donors or family members.

May 27, 2021

Over the past two decades, stem cell research at UW-Madison has grown from involving a handful of scientists to nearly 100 from more than 30 schools, colleges and departments.

May 25, 2021Quarterly Magazine, Vol. 23, No. 1

Nine University of WisconsinMadison postdoctoral researchers have been recognized with the inaugural Postdoc Excellence Awards for their teaching, service and mentoring. Daniel Z. Radecki (Comparative Biosciences) received one of these awards.

The defining feature of Dans work with the (UWMadison Postdoctoral Association) and others is his commitment to bettering the lives of all postdocs. He envisions how each event and initiative can best impact the individual, through the lenses of diversity and inclusion, immigration status, postdocs personal lives (e.g. childcare considerations), department/discipline, and more.

Congratulations, Daniel!

April 29, 2021

Researchers at UWMadison have made new photoreceptors from human pluripotent stem cells. However, it remains challenging to precisely deliver those photoreceptors within the diseased or damaged eye so that they can form appropriate connections, says David Gamm, director of the McPherson Eye Research Institute and professor of ophthalmology and visual sciences at the UW School of Medicine and Public Health.

While it was a breakthrough to be able to make the spare parts these photoreceptors its still necessary to get them to the right spot so they can effectively reconstruct the retina, he says. So, we started thinking, How can we deliver these cells in a more intelligent way? Thats when we reached out to our world-class engineers at UWMadison.

Research from the University of WisconsinMadison finds that a new therapeutic approach for heart failure could help restore cardiac function by regenerating heart muscle. In a study recently published in the journal Circulation, the UW team describes its success in improving, in a mouse model, the function of heart muscle by temporarily blocking a key metabolic enzyme after a heart attack. This simple intervention, the researchers say, could ultimately help people regain cardiac function. Our goal was to gain new understanding of how the heart can heal itself following injury at the molecular and cellular level and see if there was a way to restore cardiac function to an earlier state, says UWMadisons Ahmed Mahmoud, professor of cell and regenerative biology in the School of Medicine and Public Health.

Learn more about the research here.April 15, 2021

Grafting neurons grown from monkeys own cells into their brains relieved the debilitating movement and depression symptoms associated with Parkinsons disease, researchers at the University of WisconsinMadison reported today. In a study published in the journal Nature Medicine the UW team describes its success with neurons made from cells from the monkeys own bodies after reprogramming to induced pluripotent stem cells. UWMadison neuroscientist Su-Chun Zhang, whose Waisman Center lab grew the brain cells, said this approach avoided complications with the primates immune systems and takes an important step toward a treatment for millions of human Parkinsons patients. Learn more about their work here.March 1, 2021

The project, led by David Gamm, MD, PhD, director of the McPherson Eye Research Institute and professor of ophthalmology and visual sciences at the UW School of Medicine and Public Health, will develop a transplantable patch to restore vision to members of the armed forces who have been injured by blasts or lasers.December 11, 2020

This week, the NIH Office of Research Infrastructure Programs highlights Dr. Marina Emborg, her WNPRC lab team and their UWMadison colleagues advances in detecting heart disease in Parkinsons and evaluating new therapies that specifically target nerve disease within the human heart.December 2020

Its been 25 years since University of WisconsinMadison scientist James Thomson became the first in the world to successfully isolate and culture primate embryonic stem cells. He accomplished this breakthrough first with nonhuman primates at the Wisconsin National Primate Research Center in 1995, using rhesus monkey cells, then in 1996 with marmoset cells. Thomson then published his world-changing breakthrough on human embryonic stem cell derivation in Science on Nov. 6, 1998.November 6, 2020

EEMs and exosomes each have attractive characteristics as therapeutics, Dr. Hematti, UW-Madisons Department of Medicine, noted. As a cell therapy, EEMs will not proliferate or differentiate to undesirable cell types, which remains a concern for many stem cell therapies. Moreover, EEMs could be generated from a patients own monocytes using off-the-shelf exosomes, resulting in a faster and more facile process compared to autologous MSCs. Alternatively, exosome therapy could be a cell free, shelf-stable therapeutic to deliver biologically active components. Altogether, we believe our studies results support the use of EEMs and/or exosomes to improve ligament healing by modulating inflammation and tissue remodeling, Dr. Vanderby concluded.November 3, 2020

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Cardiac Stem Cells Comments Off on Stem Cell & Regenerative Medicine Center University of … | November 8th, 2021

Peptides don't get talked about nearly enough as some other ingredients, like hyaluronic acid, vitamin C, and retinol, but their benefits are bountiful and play a key role in improving the elasticity and plumpness of your skin. As we previously reported, peptides essentially act as tiny messengers that send messages directly to our skin cells to promote better communication. (If only they could perform the same task to better our relationships we kid.)

At their core, peptides are "chains of different types of amino acids, like glycine, arginine, histidine, etc.," David Kim, M.D., a board-certified dermatologist in New York City explains to Allure. "Peptides in skin-care products are designed to boost and replenish amino acids, which are the building blocks for collagen production." Since amino acids are the smallest unit of a protein, peptides are able to mimic another type of protein, collagen. And compared to topical collagen, peptides also have a much smaller particle size and can actually be absorbed into your skin.

"By boosting collagen production, [peptides] can help reduce the appearance of fine lines and make the skin firmer," Dr. Kim says, adding that everyone can incorporate and benefit from using the powerhouse ingredient in their routines. To that end, he says that you shouldn't experience any side effects while using peptides. "If someone has a [negative] reaction, it's most likely from the preservatives, other chemicals, or essential oils in the formula, not the peptides," Dr. Kim explains.

Mature skin can definitely benefit from peptides since, unfortunately, our bodies start to produce less and less collagen as we age. And, not to mention, the quality of said collagen also decreases over time, board-certified dermatologist Corey L. Hartman, M.D. who is based in Birmingham, Alabama, explained to us. As a result, wrinkles start to form and skin begins to sag.

Common categories of peptides consist of signal, carrier, enzyme-inhibitor, and neurotransmitter-inhibitor depending on how they work. For example, copper peptides activate wound healing, which, in turn, stimulates collagen production. But that's a bit hard to remember, especially considering that labs and brands can and do trademark their own peptide complexes.

As a consumer, you'll often find "peptide" placed front and center on the actual product packaging, you can also look out for ingredients like dipeptide, tripeptide, and hexapeptide. It's not uncommon to see multiple peptides strung together to maximum their collagen-boosting benefits, like Paula's Choice Peptide Booster and The Ordinary "Buffet."

To help you sort out the vast market, we asked dermatologists and our very own Allure editors to recommend their favorite peptide skin-care products, so you can be well on your way to achieving smoother, firmer skin.

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15 Best Peptide Skin-Care Products 2021 for Smoother, Firmer, and Plumper Skin - Allure

Skin Stem Cells Comments Off on 15 Best Peptide Skin-Care Products 2021 for Smoother, Firmer, and Plumper Skin – Allure | November 8th, 2021

Radiofrequency microneedling is the go-to procedure of Marie Hayag, M.D., a New York City dermatologist, for speedy results and recovery. "It's a simple and quick non-surgical procedure," she says. "No one wants downtime."

The first phase of the treatment is microneedling to create microscopic, quick-healing wounds deep in the dermis. "When you put needles in the skin, it induces a cascade of events for your skin to respond to produce more collagen and elastin," Dr. Hayag explains.

Then, Lutronic Genius takes skin plumping and tightening one step further by pairing up the painless pinpricks with radiofrequency to heat up the skin and create thermal damage. As a result, the whole process "expedites the production of collagen and elastin," causing skin to contract, tighten, and improve fine lines, wrinkles, and sagging, Dr. Hayag says. Best results appear after a series of three treatments, timed one month apart.

On the day of the procedure, you can expect your face to be covered in some "point marks of blood" and minimal scabbing, Dr. Murphy-Rose says, while Dr. Hayag recommends patients skip wearing makeup for 24 hours to let the needle wounds heal. In the three to five days following, redness and a bit of peeling may occur, too.

Dr. Idriss also loves microneedling with heat so much so she performed three treatments a month apart on herself. Two months into the series of procedures, "I remember looking at my eyes, thinking, 'Wow, those fine lines under my eyes are so much better,'" she recalls.

In general, radiofrequency microneedling devices offer "the best bang for someone's buck" about $1,500 to be exact as their results pack very little downtime and maximum efficiency without causing "an enormous amount of trauma" to skin, says Paul Jarrod Frank, M.D., a board-certified cosmetic dermatologist in New York City.

Clear + Brilliant Touch for Texture and Discoloration

Another newer, noninvasive innovation Dr. Murphy-Rose recently added to her device lineup is the Clear + Brilliant Touch laser, which she considers a safer, more low-key alternative to the laser gold standard, Fraxel.

With a typical Fraxel treatment, patients are sedated for the procedure, which resurfaces skin to diminish sun damage, discoloration, and fine lines, followed by wound care for the first 24 hours. Fraxel notoriously requires serious downtime, complete with redness, peeling, and discomfort for at least a week. Also, its pricey starting around $7,500, depending on the area you're addressing

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7 New Non-Injectable In-Office Treatments for Fine Lines in 2021 - Allure

Skin Stem Cells Comments Off on 7 New Non-Injectable In-Office Treatments for Fine Lines in 2021 – Allure | November 8th, 2021

By Suzy Cohen

I was talking with a friend the other day who said she is experiencing hair loss, and that it is very disappointing to her because it appears to be getting worse. She was leaning on me for advice because she said,I cant look in the mirror anymore.

She has tried all the expensive shampoos, and color treatments, she has asked her doctor, and she has finally retreated to the reality of losing her hair, when she is still a very pretty woman in her mid 70s. Basically, shes given up hope for restoration.

Within minutes I was able to discern the problem for her, and arm her with information to regrow her hair.

Todays article is to help you too. Id like to show you some more possible causes for your own hair loss in case youve given up hope yourself. Its not always because of advancing age, although that is one obvious reason.

An estimated 100 hairs are shed every day! Thats hard to believe, but its true. If youre not growing new hairs, the hair loss becomes more evident. So hair loss and hair growth are two different things. You cant stop the shedding, thats natural, but you do have some control over new hair growth. You also have a little control over factors that lead to excessive hair shedding, maybe not stem cells but certainly other factors. The stem cell theory is brand new!

Stem cell studies suggest that the 1.5 grams of dead material that we shed daily (about 500 million cells) is replaced by new stem cells, and our stem cells are compromised, and lower in number as we age. The see-saw of hair growth to hair shedding tilts in favor of hair loss with higher age. But as you will soon see, my article will show what else accelerates the hair loss.

My point is that its not always about a reduction in hormones due to menopause, although that is another obvious reason. There are many common reasons that physicians can find and help you with. Im not dealing with the easy, obvious reasons for hair loss today. I want to tackle the harder, overlooked causes.

I think millions of you reading this today will benefit. At the end of the day, I feel like this: If you cant figure out the root cause of the hair loss, you are never going to solve it! So I want to help you determine the root cause because hair is important to many people. The loss of it makes people avoid looking in the mirror.

Statin Use.

People with elevated cholesterol sometimes take statin medications such as atorvastatin to help improve their ratios. A well-documented side effect of this category of medications is reduced production of thyroid hormone. And that leads to hair loss. This was exactly the problem with my friend the other day she told me she had been on a statin drug for about 2 or 3 years, and thats when her problem began. Statins, through their drug mugging effect, lead to reduced hair growth and extra shedding.

The fix for statins:Since you cant discontinue your medication, the fix for this problem is simple. Id suggest you talk to your physician and get a prescription for Cytomel or Compounded T3 timed release, or the generic drug Liothyronine which is a biologically active form of thyroid hormone. All of these require a prescription. You could also try a good thyroid supplement to support thyroid hormone synthesis. You may also want to look into one particular mineral called selenium.

Selenium supplementation all by itself may be useful because statins are a drug mugger of selenium, and without that mineral, you could become hypothyroid. For that matter, coffee is a drug mugger of iron and magnesium which also leads to hypothyroidism. You can watch my shortVIDEOabout that.

Im not recommending all of the above options, Im just giving you choices to consider. Work with your physician to determine what is best with you.

COVID.Aside from lingering issues like inability to smell properly, C*V1D can cause hair loss. A Lancet STUDY showed that 22% of hospitalized patients reported hair loss 6 months later. Its from increased hair shedding. We know that tremendous stress on the body leads to hair loss, and the hair loss occurs months later. So it may be a combination of stress from hospitalization, as well as something that the virus itself does to the body. Either way, this is a consideration for many people today who have had the respiratory illness, and now suddenly have wads of hair falling out. I would think it is temporary.

The fixfor illness:The fix here would be time and probiotics. Time will allow your body to reduce all those stress chemicals that you had during illness. The probiotics havethe ability to counteract hair loss by supporting your bodyin a unique way more specifically they can help manage new hair growth and support the health of your hair follicles which enable faster hair growth.

Certainly, other factors may be involved like antibody formation to ones own hair follicles, but that has yet to be teased out. It may very well also cause telogen effluvium which I will discuss next.

Antibiotics and Antifungals.Many people today are treating themselves for mold illness or other infections such as Lyme disease, H. pylori, SIBO, or even acne. The medications that kill organisms are well known to cause hair loss, and this begins about 2 to 4 months into drug therapy. Its often overlooked by doctors who have one goal in mind, that is to cure your infection.

But the hair loss can be profound and frightening to the patient, so Im listing this category of medications so you understand what is happening and can take action. Itraconazole therapy is widely known to cause hair loss, and the first case study I could find was from 1986. Its no secret, but the importance of this medication and similar ones for serious illness cannot be dismissed, nor can they be discontinued if they are for a life-threatening systemic infection.

The antibiotics and antifungals can interfere with your normal cycle of hair growth. The term for this is called Telogen effluvium which causes the hair roots to be forced into a resting state. Telogen hair shedding is a condition can be acute or chronic and with medications, I would guess its chronic until discontinuation of the offending agent. After that it may take 6 months to a year to regrow.

The fix for antibiotics and anti-fungals:Probiotics can help for the same reason I explained earlier in this article. Probiotics have a counter effect to the intestinal damage done by the antibiotics. Looking into natural remedies may also be useful to some of you if the medications are too harsh. For example, Oil of Oregano and Enteric Coated Peppermint Oil capsules, Andrographis, and even Berberine are useful for some situations like SIBO, and Lyme, systemic mycosis and more! There are hundreds of choices when it comes to natural antimicrobials. If you can talk to your doctor about using more simple remedies, then perhaps the hair loss will not be so profound.

Collagen Loss.As we age, our ability to produce collagen diminishes. Because collagen protects the skin, and the layer of skin that holds the hair roots, it may help indirectly with age-related hair loss. To be clear, collagen is not really in the hair, it simply supports the hair follicle. Collagen production goes down with age, so its one piece of the puzzle.

The fix for collagen loss:Consider collagen peptides which go on to form collagen in the body. It can support healthy beautiful skin, as well as hair since the collagen peptides help build hair proteins and strengthen skin around your hair roots.

Reduced Parathyroid Hormone.The condition is termed Hypoparathyroidism. This has nothing to do with the thyroid gland, it is another set of glands that reside behind your thyroid gland, and there are four of them. The parathyroid glands regulate calcium and produce parathyroid hormone or PTH.

Symptoms of low parathyroid hormone include brittle nails, patchy hair loss, thinning eyebrows, anxiety and sometimes muscle weakness, fatigue and headaches. Most doctors do not test for the condition, but its quite common. So is the opposite condition called Hyperparathyroidism where the parathyroid glands produce too much parathyroid hormone (PTH).

If you have low PTH, you will experience hair loss and you can go for years without them figuring this out!

The fix for low PTH:Test yourself by self-ordering your own blood test, or asking your doctor to test forPTH hormone, along with vitamin D, serum calcium and ionized calcium.All four of these tests is critical. You will go from there when you get your results because the treatment for low PTH is different than the treatment for high PTH.

Oftentimes, the treatment for low PTH is simple, and nutrients are used, or PTH hormone is given to restore declining levels. But either way, at least you will know if your hair loss is being driven by a problem of the parathyroid glands. There is more information in thisPAPER

for doctors reading this today who want to understand the mechanisms behind the PTH-driven hair loss.

A PTH blood test, along with the others listed above is a very simple, affordable way to evaluate any person experiencing chronic fatigue and hair loss! If left untreated, the PTH imbalance can lead to heart problems such as Left Ventricular Hypertrophy and more. The best site for information on the parathyroid gland isparathyroid.com.Ive also written an article about calcium and PTH which may be useful and it is availableHERE.

Autoimmune Process.Many people suffer with autoimmune disease and do not even know it. Thats because the symptoms get treated one by one, with one medication at a time.You have joint pain, you get celecoxib.You have fatigue, or night sweats, youll be given an antidepressant or estrogen drug.You have neuropathy, you get gabapentin.You have a few white spots on your skin, so now you get clobetasol or betamethasone.You get a low thyroid test, so you are put on levothyroxine.You have dry eyes or dry cough, youll be given a few more drugs!

All of these symptoms could actually be autoimmune driven. In the same respective order, it would look like this:

You have joint pain, it might be Rheumatoid Arthritis.You have neuropathy, it could be Small Fiber Neuropathy, Multiple Sclerosis or Autoimmune NeuropathyYou have fatigue, or night sweats, it may be Sarcoidosis.You have a few white spots on your skin, you could have Vitiligo.You have dry eyes or dry cough, you may have Sjgrensdisease.You get a bad thyroid test, you may haveHashimotos thyroiditisorGraves disease.

My point is to make you wonder if youve been diagnosed properly, because if you have any one of these autoimmune disorders, you could also have antibodies against your own hair follicles. Hair loss is very common with all of the conditions above. Autoimmune illness is a very common, but overlooked cause for hair loss. Another one that comes to mind that I didnt list above is Celiac disease. Because the gut cannot absorb all the nutrients like normal, a deficiency may occur, which then affects hair growth. Many laboratories today test for autoimmune illness.

The fix for autoimmune process:First of all, make sure you are diagnosed properly. If you think your hair loss is being driven by an autoimmune process, you can look into new, appropriate methods of treatment. What I mean specifically, is if you are only being treated for dry eyes with a fish oil supplement, but you find out that you actually have Sjgrens, then you can get proper treatment for the Sjgrens and that in and of itself may slow down the hair loss. Improper treatment of an autoimmune process only allows the self-attack to continue. So one fix is getting adequate, proper treatment for your specific illness and your physician will help you do that. The other fix for an autoimmune illness is to improve your diet. Nothing makes the body weaker than eating junk food, and exposing yourself to more free radicals which increase the inflammatory cytokines. So a clean, healthy, well-balanced diet is critical. Gluten and casein are two common proteins which exacerbate autoimmunity.

In closing, there are many common, but overlooked causes for hair loss. I encourage you to do more searching into the possible reasons behind your hair loss, and not to give up. As always, I would urge you to consider taking nutrients that are known to support hair growth and eating a healthy diet that excludes unhealthy oils and refined or manufactured foods. I would also encourage you to avoid excessive or harsh hair treatments which can ultimately contribute to hair loss.

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Common But Overlooked Causes for Hair Loss - The Cherokee Scout

Skin Stem Cells Comments Off on Common But Overlooked Causes for Hair Loss – The Cherokee Scout | November 8th, 2021

Whether you're still coming to terms with that earlier pre-commute wake-up call or being kept awake by the little ones on the nightly, it's likely you're feeling (and seeing) the results of disrupted sleep. According to a study from the University of Southampton, the number of people experiencing insomnia rose from one in six to one in four during the height of the pandemic and the majority are experiencing more of the same.

'The last 18 months have been turbulent, and we need to prioritise sleep more than ever', says Dr Anna Persaud, CEO of This Works. 'It is essential good health, well-being and quality of life.'

Nights spent tossing and turning have an impact on our energy levels and yes, our skin too.

Skin cells have their own schedule. Sleep paves the way for their 'repair and renew' phase, that's when stem cells work to replace old cells with bright, shiny, new fully-functioning ones. The less sleep we get, the less efficient this process is. Enter dull, lacklustre skin. So, how to combat it?

According to skincare and laser specialist Debbie Thomas, gentle exfoliation can mimic the glow you get from a great night's sleep. 'To brighten up the skin first of all address your exfoliation. Gentle and regular is best, I always recommend a liquid exfoliator over a scrub, think acids or enzymes.'

Work vitamin C into your morning skincare routine too. 'Vitamin C is known for its brightening qualities,' explains Thomas, 'and with consistent use it also helps boost collagen levels too.' Never underestimate a two-pronged approach.

Who doesn't wake up with a slightly puffy face in the morning? Puffiness comes from fluid retention and fluid retention can be eased with a gentle lymphatic drainage massage. 'De-puffing your face takes a little gentle arm work', says Thomas. 'While washing your face with a slippery cleanser, use the heel of your hand to firmly massage up and out in sweeping movements to push the fluid build-up towards your ears and the lymph nodes. The idea is to push up to lift then sweep out to drain. Just make sure that your skin is a little slippery so that you aren't tugging at it.'

'For puffy eyes specifically, reach for something cold,' advises Thomas. 'Holding something cold against your eye area helps to tone down inflammation and puffiness. If you don't own a cryo-massage tool then grab an ice cube with some tissue, let it warm enough to be slippery on your skin then sweep it around your eyes and over your skin for 1-2 minutes.'

It goes without saying, but routine is key says This Works sleep expert Dr Anna Persaud. 'On a practical level establishing and maintaining a nightly wind down or sleep routine helps to reset and rebalance our minds. Try dimming lights, limiting brain stimulation - for example turning off Netflix an hour earlier and disconnecting from our devices - can help to signal to our brain that it is time to sleep.'

And from a beauty perspective? Never knock the instant results of a decent under-eye concealer.

This new overnight mask is infused with kombucha to help combat irritation and redness, and niacinamide for super soft, supple skin. Simply pop on overnight and let it get to work whilst you sleep, leaving skin refreshed, energised and glowy with minimal work. A time saving treasure.

A one stop shop for refreshed and rejuvenated skin, the Essential Skin Grade treatment combines the necessary services for your skin concerns as recommended by consultation. Think mild peels, extractions, microdermabrasion, Byonik pulse triggered cold laser, photodynamic red and blue light therapy, lymphatic drainage, radiofrequency, and ultrasound product infusion, as well as an assortment of serums and masks

"Our collection of pillow sprays all contain a clinically proven Sleep Superblend to you fall asleep faster. A natural, aromatherapeutic fragrance with 100% natural essential oils including French Lavender, wild Camomile and Vetivert. The Sleep Plus, Love Sleep and Deep Sleep Pillow Sprays calm both the mind and body and target various sleep issues. Independent consumer studies found that after using the product, 97% reported less broken sleep and 89% said they fell asleep more quickly than usual. As a result of using Deep Sleep Pillow Spray, 98% felt more relaxed in the morning and 97% felt less tired the day after using. We've sold over 8 million pillow sprays thanks to ongoing scientific research and continuous product innovation so it's fair to say they really work." Dr Anna Persaud, CEO, This Works and VP Skincare & Topicals, Canopy Growth

Angela Caglia's ultra-luxurious Self Love Rose Quartz Eye Mask is garnering a cult following for its calming and soothing properties. If you're drawn to the energy in crystals, real rose quartz is woven together to create a pampering eye mask to release tension and focus the mind. Sign us up.

"You don't need us to tell you that sleeping is a fundamental part of a healthy lifestyle", says Becky O'Neill, Global Brand Manager of Sanctuary Spa. "It improves concentration levels, mood and ability to cope with stress. Getting a good night's rest also lowers the levels of cortisol in the body, promoting a healthy and stress-free mindset". So soak away the days stress with Sanctuary Spa's wellness bath salts. The rest of the range includes a CBD calming oil, de-stress balm and pillow spray to help you properly unwind from bath to bed.

To touch up dark circles on the go, this full coverage but easily blendable concealer has a smooth, buttery formula that blends seamlessly into skin for a brightening lift. The best part? It doesn't dry out and crack, so this second skin will last as long as your day does.

This lightweight but potent serum packs a punch to give fatigued skin a dose of Vitamin C for a brighter complexion, and perceptibly plumper and more even skin. Use before moisturiser for a shot of extra hydration.

According to Slip, 'by the time we are 60 we will have slept for an average of 20 years' so better make that time count. This pure silk eye mask (and accompanying range of pillowcases) are anti aging, anti sleep crease, anti bed head and can help to reduce friction and irritation on delicate facial skin. Perfect for blocking out the early morning light and getting you to sleep through to your alarm.

Ease tense and aching joints with this concentrated CBD balm that is a non-greasy and easily absorbed formula, to massage into localised areas and melt away stress.

Aromatherapy is great for unwinding, and this calming and tranquil scented candle has notes of Lavender and Ylang Ylang. to help you take a moment to ground yourself and reset.

READ MORE: The Best Body Scrubs To Soften Dry Winter Skin, Fast

READ MORE: November 2021 Beauty Edit: The Best New Beauty Buys Out This Month

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How To Look Less Tired According To Experts | Grazia - Grazia

Skin Stem Cells Comments Off on How To Look Less Tired According To Experts | Grazia – Grazia | November 8th, 2021

NEW YORK Tara Biosystems and Scipher Medicine said Wednesday that they have entered a collaboration to identify therapeutic targets for drug development in cardiac laminopathies.

Scipher aims to use its Spectra platform to identify potentially therapeutic targets from among proteins found both up- and downstream of LMNA for a stratified disease population, while incorporating data from Tara's Biowire II LMNA disease models.

These human cardiac tissue models derive from induced pluripotent stem cells and include a repertoire of healthy, gene-edited, patient-derived, and drug-induced phenotypes of human disease. "The TARA platform is highly versatile and can capture robust physiologic endpoints of human cardiac function, including contractility, electrophysiology, calcium signaling, [and] structure, as well as genomic, proteomic, and metabolic profiles," Robert Langer, a member of Tara Biosystems' board of directors, said in a statement.

Meanwhile, Scipher's Spectra platform "uniquely integrates AI with the protein network of human cells to identify novel targets in highly complex and debilitating diseases such as laminopathy," Slava Akmaev, chief technology officer and head of therapeutics at Scipher Medicine, said in a statement. "By interrogating the network neighborhood of LMNA and its relationship with the proteins appropriate for targeted therapeutics we are confident that we can identify several novel and relevant drug targets."

In this collaboration, Tara has the exclusive option to pursue drug discovery and clinical development of any identified targets and retains the rights to develop and commercialize any resulting therapeutics. Scipher is eligible for milestone payments and royalties.

"The ability to quickly validate novel targets identified by Spectra on Tara's human tissue model platform allows us to rapidly iterate to identify most effective target," Scipher CEO Alif Saleh said in a statement.

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Tara Biosystems, Scipher Medicine Partner to Find Therapies for Cardiac Laminopathies - GenomeWeb

Cardiac Stem Cells Comments Off on Tara Biosystems, Scipher Medicine Partner to Find Therapies for Cardiac Laminopathies – GenomeWeb | November 8th, 2021

Twenty years ago, cardiologist and stem-cell scientist Piero Anversa published an exciting paper. He was then a prominent researcher at New York Medical College in Valhalla, and his data in mice showed that injured hearts could regenerate with the help of stem cells taken from bone marrow1contrary to prevailing wisdom.

Myocardial infarction, commonly known as a heart attack, deprives cardiac muscle cells of oxygen, causing them to perish. The human heart responds by laying scar tissue over lost muscle. But these reconstituted areas dont pump blood as competently as before. In time, this can lead to heart failureparticularly if other heart attacks follow. The implications of Anversas work were clear: stem cells, through their growth and proliferation, had the potential to reverse the damage caused by heart attacks and thereby prevent heart failure.

But other researchers who attempted to replicate these mouse studies found themselves coming up short. Allegations of faked results eventually began to surface, and Anversa, who had since joined Harvard Medical School, and Brigham and Womens Hospital in Boston, Massachusetts, was forced to leave his posts in 2015. Two years later, Brigham and Womens Hospital paid the US government US$10 million to settle allegations that Anversa and his colleagues had used fraudulent data to apply for federal funding. And a 2018 investigation conducted by Harvard called for 31 of Anversas papers to be retracted.

This saga has dampened the enthusiasm that once surrounded research into stem-cell therapy, says Michael Schneider, a research cardiologist at Imperial College London. The controversy, overt scientific misconduct and evidence against Anversas claims has cast aspersions on the field more generally, he admits. Thats unfortunate, because many other stem-cell scientists are conducting legitimate research.

Meanwhile, another heart-healing strategy has emerged, drawing inspiration from species that, unlike humans, can regrow cardiac muscle after trauma. Researchers are seeking to learn more about the molecules produced by zebrafish (Danio rerio) hearts as they heal themselvesand are investigating whether injectable drugs containing the same substances could also yield reparative results.

The question is now whether it will be stem cells, small-molecule drugs or a combination of the two that achieve the goal of convincing the heart to heal instead of scar.

In the wake of the Anversa scandal, there has been an important evolution of thinking on the stem-cells front. A 2019 literature review pointed out that newer studies tend to show the most significant impact from stem-cell therapy comes from the substances the cells secrete, rather than their proliferation2. After many years of work, we find that when we deliver cells into the heart, the benefit of replaced damaged cells is only minor, says the reviews author Javaria Tehzeeb, an internal-medicine specialist at the Albany Medical Center in New York. The real work of regeneration happens, she explains, when the cells produce growth factors, which in turn affect heart repair by reducing inflammation and stimulating the development of new heart muscle.

That means stem-cell therapies share some similarities with the drug strategyessentially it comes down to molecules secreted by the stem cells versus molecules that are directly injected. But they also have important differences.

First, part of the stem-cell therapy benefits might still come from the cells proliferation, even if that bonus is relatively small. Second, theres little control over what substances the stem cells produce once theyre injected, whereas specific molecules can be administered at known doses. And finally, the logistics of scaling up and delivering these two therapies will be very different.

A study published in 2020 showcased the importance of stem-cell-produced molecules by looking at the structural integrity of proteins found in infarcted mouse hearts3. The scientists artificially induced heart attacks in eight adult mice. Four weeks later, they administered stem cells to half the rodents. After a further four weeks, their hearts were removed and washed with a series of buffer solutions and chemical reagents to extract the proteins, which were then analysed. We essentially did a massive scan of every single protein in the heart, says Andre Terzic, lead author of the study. The authors were able to identify almost 4,000 proteins, and showed that heart attacks distorted the structure of 450 of them. But with stem-cell therapy, that number fell to 283.

Proteins are the intimate components that make our hearts work properly, and when the heart is diseased, they become damaged, says Terzic, who is director of the Mayo Clinic Center for Regenerative Medicine in Rochester, Minnesota. The ability of these stem cells to secrete healing signals is probably a key element to what weve observed.

All cells and tissues are constantly telling each other what they need and whether theyre stressed through molecular signalling. When you lose a chunk of cells in a heart attack, you lose part of that conversation, explains Charles Murry, an experimental pathologist and director of the Institute for Stem Cell and Regenerative Medicine at the University of Washington in Seattle. Injected stem cells could be filling in the missing dialogue by secreting signalling and rescue molecules, he explains.

Although this sounds encouraging, there are still parts of the stem-cell-therapy approach that need to be finessed. In a 2018 study, Murry and colleagues transplanted approximately 750 million cardiomyocytes into macaque monkeys that had experienced major heart attacks4. One month after the intervention, the amount of blood pumped by their hearts had increased by 10.6% compared with just 2.5% in the control group. This advantage persisted three months later, but one out of the five stem-cell-treated monkeys suffered arrhythmias. The onset of arrhythmia wasnt previously observed in small-animal studies, but it is a known complication of heart attacks. Nevertheless, the researchers thought it could be a potential side effect of the stem-cell infusion. Obviously it isnt statistically significant, but common sense led us to classify this as a treatment complication, says Murry.

In addition to safety concerns, stem-cell therapies are also beset by questions of practicality. Think of a lab with all these cell culture flasks where you have to grow millions of cells just to create a single dose, says Terzic. Now imagine tens of thousands of patients. Its a formidable effort to be ready, especially if you want to intervene rapidly. You dont have the luxury of time to build up supplies.

Thats one reason why some people think the promise of cardiac rejuvenation lies elsewhere. Theres been an awful lot of time and money spent on stem-cell therapy, raising false hope in patientsand so far, the clinical outcomes have been largely disappointing, says Paul Riley, a cardiovascular scientist at the University of Oxford, UK. Riley is investigating whether inserting specific molecules into the heart might be more effective.

Human hearts cant regenerate on their own, but other animals do have such abilities. Zebrafish, for example, can regrow their hearts after as much as 20% is removed. Newborn mice can also regenerate heart tissue. Observing the molecular pathways in these animals might make similar results possible in humans.

Research has shown that following a myocardial infarction in zebrafish, the epicardiuma membrane surrounding the heart muscleproduces molecular signals that might kick-start muscle-cell regeneration5. The hope is that manipulating the human epicardium could elicit the same therapeutic results. There are probably approaches we can take to target the cells that exist in the heart with small molecules or drugs, that could invoke repair and regeneration, says Riley.

Back in 2011, Riley and colleagues showed that this is theoretically possible6. They pre-treated adult mice with a daily injection of a protein called thymosin 4 for one week before inducing an infarction, and found that these mice were able to produce new cardiac muscle. This offers a road map to a pre-emptive therapy. If an individual is at high risk of a heart attack, says Riley, then its conceivable they could be advised to take a priming or preventative therapeutic, which may counteract an event, but its not quite the holy grail of restoring lost tissue after a heart attack that were searching for. In other studies, Riley has since shown that other proteins besides thymosin 4 might also have a role in stimulating the epicardium to regenerate the heart7.

Its easier to see how the drug route offers clearer prospects for scaling upbut the science behind this approach is newer, and there havent been any clinical trials in humans yet. What goes in stem cells favour is the body of work behind them, says Tehzeeb.

It might be that stem-cell therapies achieve government approvals first, but then drugs overtake them once the science and research have had time to catch up. When we get to the end of the line with molecules, then maybe we can say stem cells are a thing of the past, Tehzeeb says. But until then, we should continue to pursue their potential.

Murry echoes that sentiment, arguing that findings from both camps could end up helping everyones research. We need an ecosystem with a competition of ideas, and as long as its all openly published then well figure it out, he says. Thats the better approach, rather than saying my idea is better than your idea.

This article is part ofNature Outlook: Heart health, an editorially independent supplement produced with the financial support of third parties.About this content.

Orlic, D.et al.Nature410, 701705 (2001).

Tehzeeb, J., Manzoor, A. & Ahmed, M. M.Cureus11, e5959 (2019).

Arrell, D. K., Rosenow, C. S., Yamada, S., Behfar, A. & Terzic, A.npj Regen. Med.5, 5 (2020).

Liu, Y.-W.et al.Nature Biotechnol.36, 597605 (2018).

Cao, J. & Poss, K. D.Nature Rev. Cardiol.15, 631647 (2018).

Smart, N.et al.Nature474, 640644 (2011).

McManus, S.et al.J. Mol. Cell. Cardiol.140, 3031 (2020).

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Cells or drugs? The race to regenerate the heart - Scientific American

Cardiac Stem Cells Comments Off on Cells or drugs? The race to regenerate the heart – Scientific American | November 8th, 2021