The SA Bone Marrow Registry (SABMR) says their ability to recruit new donors has been severely limited by the outbreak of the second Covid-19 wave.

SABMR head of donor recruitment Nadia Chalkley said they typically recruit a few hundred new donors each year from the Eastern Cape.

The shrinking pool of donors has had a material impact on our ability to match patients suffering from life threatening blood diseases with suitable donors, she said.

At any given time, there are more than 200 patients in SA that need a bone marrow transplant. The fewer donors we have, the lesser the chance of finding a match. For patients with leukemia, thalassemia and other blood disorders, a bone marrow transplant is their only hope of survival.

Chalkley said the the current odds of finding a successful match is about one in 100,000 and will only get worse as the donor pool continues to shrink.

Sadly, more than 70% of patients struggle to find a stem cell match within their own families, which means many rely on strangers for a second chance at life.

If local donors are not forthcoming, we have to look overseas for potential matches, which is costly.

She said SABMR was working hard to ensure the safety of donors and patients by allowing online registration.

We also offer at-home sampling kits, which only requires a cheek swab. These kits can be delivered and collected free of charge from anywhere in the country.

Once new donors have completed the online registration form, they will be contacted by one of our consultants to discuss the easiest way of dispatching and collecting the kits.

One of the biggest misconceptions with regards to bone marrow donation, according to Chalkley, is that it involves large needles being pushed into ones spine.

However, the most common form of donation is whats called peripheral blood stem cell collection, since the same blood-forming cells found in bone marrow are also present in circulating blood.

The process is similar to donating plasma and doesnt require surgery.

In order to register as a bone marrow donor, you must be between the ages of 16 and 45 and meet the required standards listed by the SABMR.

A full list of the criteria can be found at https://sabmr.co.za/.

Each of us have a role to play. This new year, put away frivolous resolutions and rather direct your energy into making a difference by signing up as a donor. The simple act could just make someones new years wish come true, Chalkley said.

Visit the SABMR website, call 021-447-8638 or email donors@sabmr.co.za

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Covid-19 leads to shortage of bone marrow donors - GO! and Express

Bone Marrow Stem Cells Comments Off on Covid-19 leads to shortage of bone marrow donors – GO! and Express | January 31st, 2021

Leukemia is the cancer of blood cells, usually white blood cells which fight and clears infections. It is also known as cancer of blood-forming tissues i.e lymphatic system and bone marrow. It is usually characterized by greatly increased numbers of abnormal white blood cells in circulating blood. It is a very serious disorder and the patient needs to change the blood regularly with normal blood from donors.

By Aysha Bibi

How does leukemia develop?

Our blood contains many different types of cells. These include red blood cells, white blood cells, and platelets. These cells are made on daily basis in the bone marrow. Leukemia happens when the body starts making white blood cells beyond its need. Immature white blood cells are released in the blood and these are non-functional. Moreover, as white blood cells increase in number, the number of red blood cells and platelets are not enough to maintain a healthy life and perform their normal functions.

Types of Leukemia

Leukemia has four main types

In the acute form of leukemia, cells multiply quickly in the bone marrow and enter the circulatory system too early but these cells are immature and non-functional. Chronic leukemia occurs when marrow produces mature cells and it progresses more slowly than other forms.

Lymphocytic leukemia is a type with an accumulation of apparently mature dysfunctional lymphocytes. Normally lymphocytes differentiate to form B-cells, T-cells, and natural killer cells which are the backbone of the immune system.

Myelogenous leukemia is a cancer of white blood cells usually granulocytes and monocytes. Either it is lymphocytic or myeloid, leukemia results in a compromised immune system, and the body cannot protect itself from different infections.

Acute lymphocytic leukemia(ALL) It is most common in children. It can spread to the central nervous system.

Acute myelogenous leukemia(AML) It is the second most common type of leukemia in children and also common in adults.

Chronic lymphocytic leukemia It is common in adults. This remains stable for many years but in some types, patients need treatment.

Chronic myelogenous leukemia(CML) Older people may are at higher risk for this type of leukemia.

Risk Factors

Some significant risk factors that can cause leukemia

Symptoms of Leukemia

Various types of leukemia can cause different symptoms. These symptoms usually not appear in the early stages, but they may include;

Diagnosis of Leukemia

CBC: with a blood test doctor looks at several different blood cells and their maturity. Immature cells may appear in the blood.

Bone marrow biopsy is done by taking bone marrow. With help of this doctor check the type and severity of leukemia.

CT scan and MRI are also done for the diagnosis of leukemia.

Treatment of Leukemia

Depending on the type of leukemia and its spreading, a doctor may look for the following options:

In a radiation treatment, high energy X-rays are used to kill leukemic cells. But normal cells are also affected.

In chemotherapy, different drugs are given to kill leukemic cells in blood and bone marrow. This may include a pill or injection in muscle or vein.

Targeted therapy is done to block the expression of some genes or proteins that are involved in the production of cancerous cells.

A Stem cell transplant involves a bone marrow transplant from a healthy donor. In this method, high-dose chemotherapy is done to destroy the leukemic cells of a patient. The healthy stems cells of donor are then injected to body.

Splenectomy is the removal of spleen and doctor may look for this option if spleen becomes fills with cancer cell and start affecting other body organs.

Preventing or reducing the risk of leukemia

Unfortunately, there is currently no cure for leukemia. Minimum exposure to pesticides and radiations may help to reduce the risk of leukemia. Leukemia can also be prevented by avoiding tobacco.

One can lower the risk of developing leukemia by following:

It is the best way to lower the risk of leukemia.

Studies have shown that overweight and obesity are also contributing factors to increasing the risk of developing leukemia.

Pollution, gasoline, car exhaust contains low levels of benzene. It is also found in offices and homes and found in paint, glue, etc. wearing a mask while using these may help you lower the risk of exposure.

Medical radiations like x-rays increase the risk of leukemia. Try to avoid unnecessary radiation exposure.

Your body and mind function at their best with a healthy diet. Proper nutrition provides energy fuel for body functioning, it also strengthens the immune system.

References:

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What Is Leukemia: And How To Prevent It? - Technology Times Pakistan

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In KEYNOTE-598, the addition of ipilimumab to KEYTRUDA did not improve overall survival or progression-free survival, and patients who received the combination were more likely to experience serious side effects than those who received KEYTRUDA monotherapy, said Dr. Michael Boyer, chief clinical officer and conjoint chair of thoracic oncology, Chris OBrien Lifehouse, Camperdown, NSW, Australia. KEYTRUDA monotherapy remains a standard of care for the first-line treatment of certain patients with metastatic non-small cell lung cancer whose tumors express PD-L1.

As a leader in lung cancer, we are pursuing a broad clinical program to better understand the potential of KEYTRUDA-based combinations to improve survival outcomes for patients with this devastating disease, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. KEYNOTE-598 is the first head-to-head study designed to answer the question of whether combining KEYTRUDA with ipilimumab provided additional clinical benefits beyond treatment with KEYTRUDA alone in certain patients with metastatic non-small cell lung cancer. The results are clear the combination did not add clinical benefit but did add toxicity.

These results were presented in the Presidential Symposium at the IASLC 2020 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer on Friday, Jan. 29 and published in the Journal of Clinical Oncology. As previously announced in Nov. 2020, the study was discontinued due to futility based on the recommendation of an independent Data Monitoring Committee (DMC), which determined the benefit/risk profile of KEYTRUDA in combination with ipilimumab did not support continuing the trial. The DMC also advised that patients in the study discontinue treatment with ipilimumab/placebo.

KEYNOTE-598 Study Design and Additional Data (Late-Breaking Abstract #PS01.09)

KEYNOTE-598 (ClinicalTrials.gov, NCT03302234) is a randomized, double-blind, Phase 3 trial designed to evaluate KEYTRUDA in combination with ipilimumab compared to KEYTRUDA monotherapy as first-line treatment for patients with metastatic NSCLC without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1 (TPS 50%). The dual primary endpoints are OS and PFS. Secondary endpoints include objective response rate (ORR), duration of response (DOR) and safety.

The study enrolled 568 patients who were randomized 1:1 to receive KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle for up to 35 cycles) in combination with ipilimumab (1 mg/kg IV on Day 1 of each six-week cycle for up to 18 cycles); or KEYTRUDA (200 mg IV on Day 1 of each three-week cycle for up to 35 cycles) as monotherapy. Non-binding futility criteria for the study were based on restricted mean survival time (RMST), an alternative outcome measure estimated as the area under the survival curve through a fixed timepoint. The pre-specified criteria were differences in RMST for KEYTRUDA in combination with ipilimumab and KEYTRUDA monotherapy of 0.2 at the maximum observation time and 0.1 at 24 months of follow-up.

As of data cut-off, the median study follow-up was 20.6 months. Findings showed the median OS was 21.4 months for patients randomized to KEYTRUDA in combination with ipilimumab (n=284) versus 21.9 months for those randomized to KEYTRUDA monotherapy (n=284) (HR=1.08 [95% CI, 0.85-1.37]; p=0.74). The differences in RMST for KEYTRUDA in combination with ipilimumab and KEYTRUDA monotherapy were -0.56 at the maximum observation time and -0.52 at 24 months, meeting the futility criteria for the trial and confirming the benefit/risk profile of the combination did not support continuing the study. Additionally, the median PFS was 8.2 months for patients randomized to KEYTRUDA in combination with ipilimumab versus 8.4 months for those randomized to KEYTRUDA monotherapy (HR=1.06 [95% CI, 0.86-1.30]; p=0.72). In both arms of the study, ORR was 45.4%; the median DOR was 16.1 months for patients randomized to KEYTRUDA in combination with ipilimumab versus 17.3 months for those randomized to KEYTRUDA monotherapy.

No new safety signals for KEYTRUDA monotherapy were observed. Treatment-related adverse events (TRAEs) occurred in 76.2% of patients treated with KEYTRUDA in combination with ipilimumab versus 68.3% of patients treated with KEYTRUDA monotherapy. Of these TRAEs, 35.1% vs. 19.6% were Grade 3-5, 27.7% vs. 13.9% were serious, 6.0% vs. 3.2% led to discontinuation of ipilimumab or placebo, 19.1% vs. 7.5% led to discontinuation of both drugs and 2.5% vs. 0.0% (no patients) led to death. Additionally, immune-mediated adverse events (AEs) and infusion reactions occurred in 44.7% of patients treated with KEYTRUDA in combination with ipilimumab versus 32.4% of patients treated with KEYTRUDA monotherapy. Of these immune-mediated AEs, 20.2% vs. 7.8% were Grade 3-5, 19.1% vs. 7.1% were serious, 1.8% vs. 1.1% led to discontinuation of ipilimumab or placebo, 12.1% vs. 4.3% led to discontinuation of both drugs and 2.1% vs. 0.0% (no patients) led to death.

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10% to 15% of all lung cancers. Before 2014, the five-year survival rate for patients diagnosed in the U.S. with NSCLC and SCLC was estimated to be 5% and 6%, respectively.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-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 1,300 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 stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

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.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. 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 confirmatory trials.

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) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) 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)

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 first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. 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 recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA 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. 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.

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 patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

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) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

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

This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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 programmed death receptor-1 (PD-1) or the programmed death ligand 1 (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. 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). 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)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatments and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

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Mark Allen, CEO of Elevian, pictured above. Photo courtesy of Elevian.

Once the domain of mythical fountains of youth and movies like The Curious Case of Benjamin Button, the science of aging prevention and reversal is beginning to enter the mainstream with reputable academic institutions launching companies to accomplish this once improbable feat.

One such company, Elevian, founded by a team of Harvard scientists and physician-turned entrepreneurDr. Mark Allen, is working to restore regenerative capacity with the aim of preventing and treating age-related diseases. A critical factor, they say, is a single protein called Growth differentiation factor 11 (GDF11).

Allen, Elevians chief executive officer, first became interested in the science of aging after taking a course focused on exponential thinking.

All of a sudden, problems that were heretofore unsolvable become solvable, Allen said of the theory that is the opposite of incremental and encourages one to think outside of the box. They talked about examples of problems that weve always thought to be unsolvable, one of them being aging and longevity. So that was it for me. I was like thats perfect for me. Thats what I want to work on.

Searching for clues into the diseases associated with aging, Elevians founders, including Harvard professor of Stem Cell and Regenerative BiologyDr. Amy Wagers, mined the proteome, looking into how proteins change with age. They uncovered several, including one with potentially groundbreaking regenerative capabilities, GDF11.

Elevian believes that this single protein, a key player in the circulatory system, could be a game-changer in regenerative medicine.

GDF11 is one of those proteins that change with age, Allen said. They [the founders] really dug into GDF11 because so little was known about it at the time of their discoveries. They did side-by-side studies with the parabiosis model, injecting just GDF11, to see if it could reproduce some of the effects of parabiosis in the aged animal. And they found, much to everybodys surprise, that replenishing just this one circulating factor was able to reproduce the beneficial effects of parabiosis.

Parabiosis, which means living beside, is performed by joining two living organisms surgically to develop a single, shared physiology. It has been used to study conjoined twins, and more recently, in a 1972 lifespan study attaching old and young rats, scientists Frederic C. Ludwig and Robert M. Elashoff showed evidence of an extended lifespan for the older animals.

As a post-doc at Harvard, Dr. Wagers expanded upon this research using modern histology techniques. When Wagers and her colleagues attached the circulatory systems of young mice to old ones, they found strong evidence of a biological reversal of cardiac hypertrophy, which occurs with aging. They attributed this to GDF11 in a paper published in Science in 2014 and recognized as a runner-up to the publications Breakthrough of the Year.

What they found is that the old animals exposed to young blood experienced a biological reversal of aging by many different measures. Their brains grow younger, their hearts grow younger, their lungs, their bones all over their body. And interestingly, the young animals exposed to old blood have accelerated aging. So this is just really strong proof that circulating factors regulate aging, said Allen.

The mechanism of action appears to be that GDF11 binds directly to the endothelial projectors, the cells that line our blood vessels and improve both the quality and quantity of the vasculature. It does not cross the blood-brain barrier, so we think its mechanism is primarily by improving vasculature, he explained.

Elevian, the recent beneficiary of an initial round of seed financing, is actioning this potent protein to develop a potential regenerative treatment for stroke patients.

English biomedical gerontologist Aubrey de Grey, whom Allen credits with doing a lot to start the medical field of aging reversal, outlined several hallmarks of aging in his 2007 book, Ending Aging. These include stem cell exhaustion, protein aggregate buildup, failed intercellular communicationand senescent cells.

One of the barriers to developing therapeutics based on these factors is the inherent incongruence with the usual regulatory approval systems. Following customary protocol, proving that a drug prevents aging or age-related diseases would quite literally take a lifetime.

Theres no regulatory path for treating aging. Even doing a prevention trial would take years and years and years, because you have to take people and wait until they get disease to see effects. So instead, to get a drug to market, we take the opposite extreme. We look at what is the most devastating possible disease, unmet need, where we could treat for the shortest possible duration and see clinically meaningful effects, Allen explained.

Elevian decided on stroke, which is the number two cause of death worldwide and the third leading cause of disability.

The only existing treatments for a stroke are limited to the acute phase, where an IV injection of a drug such as recombinant tissue plasminogen activator (tPA) (Activase)restores blood flow by dissolving the clot causing the event.

In an ischemic stroke, which makes up 87% of cases, a blood clot forms and prevents blood and oxygen from reaching an area of the brain, impacting breathing and heart function and often leading to paralysis. This is where Elevian believes a drug utilizing GDF11, which acts on the circulatory system, holds such promise for rehabilitation.

Allen revealed that his team has already demonstrated GDF11s impact on stroke-stricken animals.

When we give GDF11 to animals that have had strokes and are paralyzed or have severe motor function debilitation, it returns them almost to normal function. It significantly improves motor function recovery, he said.

On the strength of these preclinical results, Elevian is gearing up to enter human clinical trials with GDF11 for the treatment of stroke.

We really got the green light to go into humans based upon the animal data that we got there, Allen said, adding that there is still a lot of work to be done before they reach this phase. We still have to scale up production of the drug and we have to do extensive safety and toxicology tests IND-enabling studies. The longest pole in the tent is figuring out how to make manufacturing costs effective. The cost of goods is going to be really, really high. So were doing a lot of work in process development right now, and then were going to hand it off to a manufacturing partner to scale up. Were about two years from initiating our human clinical trial in stroke.

Another unmet need where Elevian believes GDF11 can have an impact is Type 2 diabetes, a disorder whose pathology is also intricately connected to the circulatory system and often to aging.

Along with blood clotting factors, glucose resides within the inside lining of blood vessels. In Type 2 diabetics, the lining of an individuals blood vessels begins to become glycosylated, which causes them to narrow, impeding blood flow. Glucose tolerance is known to decrease with age.

In a study published in March 2020, Wagers and her colleagues stated that GDF11 was shown to significantly improve glucose tolerance in aged mice and increase glucose homeostasis, under a variety of dietary conditions.

Allen believes that addressing the aging process is the ultimate exponential strategy to solving a whole host of humanitys biggest killers:

This idea that we could, by targeting the aging progress, potentially promote healthy aging, promote a healthy longevity, and reduce the burden of age-related diseases, and that the same treatment could be used to treat and prevent multiple age-related diseases. That concept was like, why arent we working on that? Why are we spending billions of dollars on Alzheimers and billions of dollars on cancer, billions of dollars on heart disease? We could instead target the aging process and potentially treat them all.

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Cardiac rhythm management refers to a process of monitoring functioning of the heart through devices. Cardiac rhythm management devices are used to provide therapeutic solutions to patients suffering from cardiac disorders such as cardiac arrhythmias, heart failure, and cardiac arrests. Cardiac disorders lead to irregular heartbeat. Technological advancements and rise in the number of deaths due to increasing incidences of heart diseases and increasing aging population are some of the major factors driving the cardiac rhythm management market. Heart disease is one of the primary causes of death in the U. S. Excess of alcohol consumption; smoking, high cholesterol levels, and obesity are some of the major causes of heart diseases. Cardiac rhythm management is conducted through two major devices: implantable cardiac rhythm devices and pacemakers. Implantable cardiac rhythm devices treat patients with an improper heartbeat. Based on the device, the cardiac rhythm management market can be segmented into defibrillators, pacemakers, cardiac resynchronization therapy devices, implantable defibrillators, and external defibrillators. Pacemakers are used to treat patients with a slow heartbeat. Based on the end user, the cardiac rhythm management market can be segmented into hospitals, home/ambulatory, and others.

North America has the largest market for cardiac rhythm management due to improved healthcare infrastructure, government initiatives, rise in incidences of cardiac disorders, growing number of deaths due to cardiovascular diseases,and increasing healthcare expenditure in the region. The North America market for cardiac rhythm management is followed by Europe. Asia is expected to witness high growth rate in the cardiac rhythm management market in the next few years due to increasing incidences of cardiovascular diseases, growing disposable income, rise in awareness regarding heart disorders and relevant treatments, and improving healthcare infrastructure in the region.

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Increasing the prevalence of cardiovascular diseases, technological advancements, rise in life expectancy, increasing awareness regarding cardiac disorders, and government initiatives are some of the major factors that are expected to drive the market for cardiac rhythm management. In addition, factors such as a rise in disposable income, increasing aging population, and high cost associated with heart disease treatment are expected to drive the market for cardiac rhythm management. However, economic downturn, reimbursement issues, the importance of biologics and stem cells, and inappropriate use of the devices are some of the factors restraining the growth of the global cardiac rhythm management market.

Growing population and economies in the developing countries such as India and China are expected to drive the growth of the cardiac rhythm management market in Asia. In addition,factors such as innovations along with technological advancements such as miniaturization, introduction of MRI pacemakers, biocompatible materials and durable batteries, and continuous rise in aging population and increasing cardiovascular diseases such as arrhythmias, stroke, and high blood pressure are expected to create new opportunities for the global cardiac rhythm management market. An increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and new product launches are some of the latest trends in the global cardiac rhythm management market.

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Some of the major companies operating in the global cardiac rhythm management market areMedtronic, Abbott Laboratories, Boston Scientific, St. Jude Medical, Altera, and Sorin.Other companies with significant presence in the global cardiac rhythm management market include

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And for some families this wait is excruciating, he said at a Wednesday news conference.

Shandro said there is no specific budget or cap on how much the government will spend, but that it was working with drug manufacturer Novartis to provide access. Nearly 70 per cent of children with spinal muscular atrophy type 1 do not live past age two. The drug is typically only approved for children under two.

We just dont want kids to fall through the cracks, said Shandro.

Susi Vander Wyk, executive director of Cure SMA Canada, thanked the province for making a decision she said is saving lives.

Its a fairly new treatment, so we dont know the long-term future of it, but we sure know that it has an astounding impact on these babies, she said at the news conference.

The earlier they receive the treatment, the better their prognosis, Vander Wyk said.

Time is ticking for them.

For Lana Martin, whose two-year-old son Kaysen Martin received the Zolgensma treatment in December after fundraising and an anonymous $1.4 million donation, the news was a huge step towards more kids accessing the drug.

Its still early after Kaysens treatment, but hes already more confident in his movements and doesnt tire as easily, said Martin.

He can now officially completely roll from one side of the room to the other side of the room, and he was not able to do that before, she said.

Martin said it was difficult for her and her husband, normally private people, to advocate publicly for the drugs coverage, but shes glad they did.

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Cancer is an extremely complex disease. There are over 200 different types, some of which are considered common and others which are classified as rare cancers. But what exactly does it mean if a cancer is rare?

Usually, it means it only affects a small handful of people, but doctors might also call a cancer rare if it starts in an uncommon place in the body, or if the cancer is an unusual type and requires special treatment.

For secondary central nervous system (CNS) lymphoma, its an incredibly rare cancer for a combination of these reasons.

Secondary CNS lymphoma is a type of lymphoma thats spread to the brain and spinal cord nervous system after originating elsewhere in the body. And as well as being a rare cancer, secondary CNS lymphoma is an aggressive cancer, which has relatively low survival rates.

However, the latest results from the Stand Up To Cancer-funded MARIETTA clinical trial, which details a new potentially transforming treatment, has shed a glimmer of hope for patients and doctors alike.

We spoke to Dr Kate Cwynarski, who led the study in the UK, about what the latest results could mean for patients with secondary CNS lymphoma.

With a rare cancer such as secondary CNS lymphoma, finding a large enough group of patients can be a real challenge. And in cases like this, researchers have to think on a global scale.

Its a rare disease. So the reality of it is that you would not get this information if we just performed a trial in the UK, says Cwynarski. International collaboration is the only way to do it.

The MARIETTA trial is the largest study focused on patients with secondary CNS lymphoma, involving 24 centres across 4 countries and recruiting a total of 79 patients. It involved the International Extranodal Lymphoma Group (IELSG) lead by Professor Andres Ferreri in Italy and it built on the success of prior research with this group. In the UK, the trial was managed by CRUK Southampton CTU.

In particular, findings from a previous clinical trial partly funded by us, which tested treatments for primary CNS lymphoma, a lymphoma thats only found in the brain, helped inform the design of this clinical trial.

The IELSG-32 trial tested the benefits of an intensive chemotherapy regimen known as MATRIX, followed by either whole brain radiotherapy or a stem cell transplant using the patients own cells.

Cwynarski describes the IELSG-32 trial as practice changing, and its from these impressive results that the MARIETTA trial was developed. So we adapted a strategy that was successful in treating primary CNS lymphoma in the IELSG-32 trial and added another chemotherapy regimen, called R-ICE, to help treat the systemic disease on top of the secondary brain disease.

Cwynarski specialises in lymphoma, so she has treated SCNSL patients both on and off the trial. One of the big benefits of this trial, she describes, is that the inclusion criteria for the cohort more accurately reflected the patients she sees in her clinic and referral practice.

This trial included patients up to 70 years of age. And it wasnt just focused on fit, young people. So I have to say I think it was meaningful, because it included the kind of patients that we actually see.

The trial also included people regardless of when their secondary CNS lymphoma was diagnosed, whether that was when someone was originally diagnosed with lymphoma, during treatment, or after their cancer had come back.

And the results look promising. A total of 49 patients (65%) responded to the treatment in some way, with 37 people going on to have a stem cell transplant. 100% of the patients who had the stem cell transplant had not seen their cancer recur a year after registering onto the trial. We are optimistic many will be cured of this aggressive lymphoma.

But the trial also picked up differences between groups. While the regime was effective to an extent in every sub-group, the most significant results were seen in patients whose CNS disease was discovered at initial lymphoma diagnosis. Within this group, 71% of patients had lived for 2 years without their cancer growing.

A result which has never been seen before.

The results of the trial have completely transformed the teams optimism when meeting new patients. We really have identified a regimen which is intensive, but its potentially curative, concludes Cwynarski, and the word cure is not something weve really used before when talking about this disease.

Recently, Cwynarski has been busy filling out a cohort of her patients DVLA forms, confirming they are fit to drive again after being 2 years treatment free. So thats an amazing success and it was very symbolic as a reminder that these people have been alive and off all treatment for 2 years.

Moments like this are a reflection of the huge impact the MARIETTA trial has had for real people, like Maureen Brewster.

Maureen was diagnosed with lymphatic cancer of the liver in 2011 and was under the watchful eyes of a consultant during her treatment. But in the summer of 2016, I started to have very extreme headaches, says Maureen.

After getting an emergency appointment, she was taken to A&E and admitted to hospital straight away. I was transferred to the National Neurology hospital in Russell Square for a biopsy. They thought I might have had a stroke. But it wasnt. Instead, Maureen was diagnosed with a secondary cancer in her brain.

When Maureen was transferred to UCLH, she was told about the MARIETTA trial. I could have chosen not to go on the trial, but being part of it meant that I would get more examinations and monitoring. So it was more reassuring to be on the trial, she says.

Maureen during treatment.

Maureen went through 8 tough months of chemotherapy before having a stem cell transplant in the summer of 2017. During one round of chemo in the hospital I became ill with an infection and really thought I was going to die. The last chemo prior to me having stem cell transplant was so strong it really had an impact on me and I couldnt eat I felt very poorly for a few weeks.

Maureens stem cell transplant went smoothly and prior to COVID-19, she was having regular check-ups and scans in hospital.

Prior to the first lockdown in March 2020, Maureen was able to do some volunteering and also go back to work, teaching a course on Project Management at a local adult college. In April 2019 I also secured a part-time job as a User Involvement Co-ordinator. It was great to get back to that level.

Dr Cwynarski emphasises that while the trial was a great success for some, it also exposed a group of patients who didnt do so well on the treatment.

The results threw up a real disparity and uncovered an unmet need in a particular group of patients. For the group of patients whose cancer had already failed to respond to a chemotherapy treatment, known as R-CHOP, at the follow up of 2 years, only 20% had not experienced their cancer progressing or getting worse.

We need to target this cohort of patients in a different way, says Cwynarski. So really the challenge is, can we identify experimental agents be it different biological agents or immunotherapies such as CAR T cell therapy in the patients who have relapsed, and maybe bringing these therapies into the frontline.

Lilly

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Stem Cell Therapy Market is valued at USD 9.32 Billion in 2018 and expected to reach USD 16.51 Billion by 2025 with the CAGR of 8.5% over the forecast period.

Rising prevalence of chronic diseases, increasing spend on research & development and increasing collaboration between industry and academia driving the growth of stem cell therapy market.

Scope of Stem Cell Therapy Market-

Stem cells therapy also known as regenerative medicine therapy, stem-cell therapy is the use of stem cells to prevent or treat the condition or disease. Stem cell are the special type of cells those differentiated from other type of cell into two defining characteristics including the ability to differentiate into a specialized adult cell type and perpetual self-renewal. Under the appropriate conditions in the body or a laboratory stem cells are capable to build every tissue called daughter cells in the human body; hence these cells have great potential for future therapeutic uses in tissue regeneration and repair. Among stem cell pluripotent are the type of cell that can become any cell in the adult body, and multipotent type of cell are restricted to becoming a more limited population of cells.

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The stem cell therapy has been used to treat people with conditions including leukemia and lymphoma, however this is the only form of stem-cell therapy which is widely practiced. Prochymal are another stem-cell therapy was conditionally approved in Canada in 2012 for the treatment of acute graft-vs-host disease in children those are not responding to steroids. Nevertheless, hematopoietic stem cell transplantation is the only established therapy using stem cells. This therapy involves the bone marrow transplantation.

Stem cell therapy market report is segmented based on type, therapeutic application, cell source and by regional & country level. Based upon type, stem cell therapy market is classified into allogeneic stem cell therapy market and autologous market.

Stem Cell Therapy Companies:

Stem cell therapy market report covers prominent players like,

Based upon therapeutic application, stem cell therapy market is classified into musculoskeletal disorders, wounds and injuries, cardiovascular diseases, surgeries, gastrointestinal diseases and other applications. Based upon cell source, stem cell therapy market is classified into adipose tissue-derived mesenchymal stem cells, bone marrow-derived mesenchymal stem cells, cord blood/embryonic stem cells and other cell sources

The regions covered in this stem cell therapy market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, market of stem cell therapy is sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Africa, etc.

Stem Cell Therapy Market Segmentation

By Type

Allogeneic Stem Cell Therapy Market, By Application

Autologous Market, By Application

By Therapeutic Application

By Cell Source

Stem Cell Therapy Market Dynamics

Rising spend on research and development activities in the research institutes and biotech industries driving the growth of the stem cell therapy market during the forecast period. For instance, in January 2010, U. S. based Augusta University initiated Phase I clinical trial to evaluate the safety and effectiveness of a single, autologous cord blood stem infusion for treatment of cerebral palsy in children. The study is estimated to complete in July 2020. Additionally, increasing prevalence of chronic diseases creating the demand of stem cell therapy. For instance, as per the international diabetes federation, in 2019, around 463 million population across the world were living with diabetes; by 2045 it is expected to rise around 700 million. Among all 79% of population with diabetes were living in low- and middle-income countries. These all factors are fuelling the growth of market over the forecast period. On the other flip, probabilities of getting success is less in the therapeutics by stem cell may restrain the growth of market. Nevertheless, Advancement of technologies and government initiative to encourage research in stem cell therapy expected to create lucrative opportunity in stem cell therapy market over the forecast period.

Stem Cell Therapy Market Regional Analysis

North America is dominating the stem cell therapy market due increasing adoption rate of novel stem cell therapies fueling the growth of market in the region. Additionally, favorable government initiatives have encouraging the regional market growth. For instance, government of Canada has initiated Strategic Innovation Fund Program, in which gov will invests in research activities carried out for stem cell therapies. In addition, good reimbursing scheme in the region helping patient to spend more on health. Above mentioned factors are expected to drive the North America over the forecast period.

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EIMEAR Gooderham (ne Smyth) was just 25 when she died peacefully in hospital with her family at her bedside.

It was just a week after she had married Phillip Gooderham in hospital and she was buried in the wedding dress she never got to wear.

Almost two years on, her family hope a television documentary about Eimear - a make-up artist from the Coolnasilla area of west Belfast - will help create a positive and lasting legacy in her memory.

The programme, due to be broadcast on UTV and presented by journalist Sarah Clarke, features Eimear's own video diaries, which she had hoped would raise awareness of a campaign for stem cell donors that she launched before her death.

Ms Clarke said the documentary had aimed to "follow Eimear's journey, treatment and her recovery".

"She was very open about her battle and while a lot of the programme is distressing, it shows how courageous Eimear was," she said.

Eimear was diagnosed with stage two Hodgkins Lymphoma, a type of blood cancer, in September 2016.

She underwent 12 cycles of intensive chemotherapy and was given the all-clear in spring 2017.

But the disease returned and in December that year, Eimear was treated with an autologous stem cell transplant, intensive chemotherapy and her own stem cells returned afterwards to rescue her bone marrow from the effect of the treatment.

Months later she was given the good news she was in remission, but the Hodgkins Lymphoma returned again and doctors said her best chance of survival was another stem cell transplant - this time from a donor.

With neither of her siblings a match, she desperately needed to find a stem cell donor.

Eimear and her father Sean launched an appeal to raise awareness of the stem cell register, which allows donors of the correct tissue types to be matched with patients.

Their campaign saw the number of people joining the register in Northern Ireland soar.

Determined to use her own experience to help others, Eimear began filming videos on her phone for the UTV documentary.

Her desire to show her cancer battle as well as her upbeat outlook on life are reflected in the diaries, with many filmed as she underwent treatment.

Speaking ahead of the broadcast tonight, Ms Clarke said her own family's cancer battle had also inspired her to tell Eimear's story.

"In 2017, my nephew Jack was diagnosed with leukaemia, aged just 15," she said.

"I remember my brother Simon, who is a doctor, saying they may have to pursue a stem cell transplant. He knew how difficult it would be to find a match and to endure.

"Fortunately Jack didn't need it, but he had to undergo a year of intensive chemo and four years of maintenance chemo.

"It was rough and a very difficult period and thankfully he's now in remission, but it made me relate to Eimear and San's appeal."

On October 31 2018 - a year before Eimear and Phillip had planned to marry - she received her stem cell transplant.

A video extract of the days after the operation shows Eimear describe how "it's been really rough", as the donor's cells began attacking her cells - a condition known as graft versus host disease.

Despite being discharged from hospital, months later she became ill again with complications associated with the transplant - she was losing her brave battle.

Phillip tells the programme: "I wanted to tell her it was going to be ok, but I didn't want to lie to her. I wanted it to be over so she wasn't in pain".

In June 2019, the couple tied the knot and Eimear got "her final wish".

"We had had it planned, we had to cancel our wedding so it was, in the most horrific circumstances, the nicest way to end her life, by her getting her final wish," said Phillip.

Eimear died on June 27 2019.

Since then her family have continued to campaign to raise awareness of stem cell donation.

Her father Sean said they hope the programme will "highlight the need for more people in Northern Ireland to join the stem cell donor register, especially young men aged between 16 and 30".

Sarah also said while the documentary is "not exactly the one we set out to make, its still one of hope and courage".

"It was Eimears dying wish to raise awareness of stem cell donation and to help further research into the treatment to help others," she said.

"She was adamant she wanted people to sign the register and raise awareness. Her family feel the onus is now on them to continue this.

"The programme pays tribute to a courageous young woman and her family's desire to create a positive and lasting legacy in her memory."

Up Close: Eimears Wish is on UTV at 10.45pm.

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UTV documentary tells of young Belfast woman's lasting legacy to promote stem cell donation - The Irish News

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NEW YORK, Jan. 28, 2021 /PRNewswire/ --BrainStorm-Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the fourth quarter and year ended December 31, 2020, and provide a corporate update, at 8:00 a.m., Eastern Time, on Thursday, February 4, 2020.

BrainStorm's CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Global Head of Clinical Research ,David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. EDT, Wednesday, February 3, 2020.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:

Toll Free: 877-407-9205

International: 201-689-8054

Webcast URL: https://cutt.ly/vjBvkTp

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Number:

Toll Free: 877-481-4010

International: 919-882-2331

Replay Passcode: 39495

About NurOwn

The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

Story continues

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is in active discussions with the FDA to identify regulatory pathways that may support NurOwn's approval in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.

For more information, visit the company's website at http://www.brainstorm-cell.com.

ContactsInvestor Relations:Corey Davis, Ph.D.LifeSci Advisors, LLCPhone: +1 646-465-1138cdavis@lifesciadvisors.com

Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com

View original content:http://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-to-announce-fourth-quarter-and-fiscal-year-2020-financial-results-and-provide-a-corporate-update-301217243.html

SOURCE Brainstorm Cell Therapeutics Inc

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BrainStorm-Cell Therapeutics to Announce Fourth Quarter and Fiscal Year 2020 Financial Results and Provide a Corporate Update - Yahoo Finance

Bone Marrow Stem Cells Comments Off on BrainStorm-Cell Therapeutics to Announce Fourth Quarter and Fiscal Year 2020 Financial Results and Provide a Corporate Update – Yahoo Finance | January 29th, 2021

National Institute for Health and Care Excellence (NICE) recommends lenalidomide as a maintenance therapy for people with newly diagnosed multiple myeloma who have undergone a stem cell transplant

Uxbridge, UK, 27th January 2021: Celgene, a Bristol Myers Squibb (BMS) company, today announces that NICE has issued a Final Appraisal Document (FAD) recommending REVLIMID (lenalidomide) as maintenance treatment after an ASCT for newly diagnosed multiple myeloma in adults.[iv] From today, approximately 1150 eligible patients in England will have immediate access to lenalidomide as a treatment option, with interim funding provided via the Cancer Drugs Fund (CDF) before transferring to baseline commissioning. Lenalidomide is the first treatment to be made available on the NHS in this setting and provides an alternative to the standard watch-and-wait approach, allowing patients to receive active treatment to keep their cancer in remission.

Graham Jackson, Professor of Clinical Haematology at Newcastle Upon Tyne NHS Foundation Trust said: Multiple myeloma is a relapsing remitting disease where the goal of treatment is to ensure long periods of remission and a good quality of life. Maintenance therapy is integral to achieving this, particularly for newly diagnosed patients who have received a stem cell transplant. Having lenalidomide within our treatment armoury on the NHS will transform the way we manage the early stages of multiple myeloma. In clinical studies maintenance therapy has been shown to almost double the initial period of remission for this group of patients, so it is fantastic to be able to offer active treatment which can help to keep the cancer at bay.

Multiple myeloma is a cancer that affects the production of plasma cells in the bone marrow and in turn impacts the bodys immune system.[v] It is characterised by a relapsing-remitting pattern, which means that the disease goes through periods where the cancer is active and needs treatment, followed by periods where it is under control.[vi] Each time the cancer relapses, the length of time spent in remission shortens.[vii] The objective of maintenance therapy is to control the cancer during the period of remission and delay relapse of the disease.[viii]

Laura Kerby, Chief Executive of Myeloma UK said: We are delighted with this outcome. Patients who receive lenalidomide maintenance after high-dose therapy and stem cell transplant have a significant increase in overall survival, so the decision to make this available through the NHS is fantastic news.

Across the UK, around 1,500 newly diagnosed multiple myeloma patients undergo an ASCT each year,1,2 and most of them will eventually relapse.[ix] This first remission is a critical period for people with multiple myeloma, as it can be an indicator of the overall survival of the disease and it has been shown that effective maintenance therapy could be essential to long-term survival.[x]

Lynelle Hoch, General Manager at Bristol Myers Squibb UK & Ireland commented: Todays announcement marks an important milestone for those living with multiple myeloma, with lenalidomide being the first maintenance treatment option to be made accessible to eligible patients in England. We are grateful for the continued collaboration with NICE, healthcare professionals and Myeloma UK to ensure patients can benefit from lenalidomide in this setting.

Following the publication of this guidance, the NHS in Wales is expected to provide funding and resources for lenalidomide in this setting within two months. The treatment is already available on the NHS in Scotland and in Northern Ireland.[xi],[xii]

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National Institute for Health and Care Excellence (NICE) recommends lenalidomide as a maintenance therapy for people with newly diagnosed multiple mye...

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[Courtesy of ToolGen]

SEOUL --ToolGen, a South Korean developer of genome editing technology, tied up with T&R Biofab, a 3D bioprinting company, to cooperate in applying induced pluripotent stem cells to gene correction. ToolGen has original technology related to third-generation gene scissors to cut out genetic information in cells.

Induced pluripotent stem cells (iPSCs) are derived from skin or blood cells that have been reprogrammed back into an embryonic-like pluripotent state that enables the development of an unlimited source of any type of human cell needed for therapeutic purposes. iPSCs can be derived directly from adult tissues and bypass the need for embryos.

ToolGen signed a memorandum of understanding T&R Biofab, which prints human organs and tissues for clinical transplantation, to develop and utilize cells that combine iPSCs and gene calibration technologies. "Inductive pluripotent stem cells are an ideal platform for developing gene correction therapy because they can be segmented into various cells," said ToolGen co-CEO Kim Young-ho.

ToolGen has partnered with VivaZome Therapeutics, an Australian biotech company, to develop therapies based on exosomes which are recognized for their critical role in cell-to-cell communication and transportation. The market for exosome therapeutics has been growing rapidly, and many life science companies have launched tools and systems to support exosome research.

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ToolGen ties up with 3D bioprinting company to apply induced pluripotent stem cells to gene correction - Aju Business Daily

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News Release

Thursday, January 28, 2021

Approach could provide new path for difficult-to-treat forms of Leber congenital amaurosis.

Scientists at the National Eye Institute (NEI) have developed a promising gene therapy strategy for a rare disease that causes severe vision loss in childhood. A form of Leber congenital amaurosis, the disease is caused by autosomal-dominant mutations in the CRX gene, which are challenging to treat with gene therapy. The scientists tested their approach using lab-made retinal tissues built from patient cells, called retinal organoids. This approach, which involved adding copies of the normal gene under its native control mechanism, partially restored CRX function. The study report appears today in Stem Cell Reports. NEI is part of the National Institutes of Health.

Our treatment approach, which adds more copies of the normal gene, could potentially treat autosomal-dominant LCA caused by a variety of mutations, said Anand Swaroop, Ph.D., chief of the NEI Neurobiology, Neurodegeneration and Repair Laboratory and senior author of the report.

The U.S. Food and Drug Administration approved Luxturna in 2017 for the treatment of LCA patients with mutations in a gene called RPE65. Although hailed as a major advance in gene therapy, Luxturna is ineffective against other forms of LCA, including those caused by autosomal-dominant mutations in CRX.

The CRX gene encodes a protein (also called CRX) that binds to DNA and instructs the retinas photoreceptors to make light-sensitive pigments called opsins. Without functional CRX protein, photoreceptors lose their ability to detect light and eventually die.

Disorders like autosomal-dominant LCA are tricky to treat with gene therapy, because adding more of the normal gene does not always restore function. People with autosomal-dominant mutations still have one normal copy of the gene, but the mutant version of the protein interferes with the normal protein. Sometimes, instead of restoring normal function, simply adding more of the normal protein can enhance the disease in unpredictable ways.

To explore how gene augmentation adding copies of the normal gene would affect autosomal-dominant LCA, Swaroops team, developed retinal organoids from two volunteers with LCA and from their unaffected family members. Led by Kamil Kruczek, Ph.D., a postdoctoral fellow in Swaroops lab, they built the complex retina-like tissues in several stages, starting with skin cells, inducing the production of mature photoreceptors and other retinal cells with the genetic profile of each volunteer. As expected, patient organoids made far less light-sensing opsin than the organoids made from unaffected family members.

To carefully control how much CRX gene would be expressed by the recipient photoreceptors, the team re-engineered the CRX promoter so it could be delivered with the CRX gene as part of the gene therapy. A promoter is a neighboring sequence of DNA that controls when and how genes are expressed. The researchers packed the gene and their engineered promoter inside a virus that shuttled them into the organoid photoreceptors.

The teams gene augmentation strategy restored some CRX protein function for organoids from both patients, driving expression of opsins in both types of photoreceptors: rods and cones.

The fact that this strategy worked for both CRX mutations was pretty exciting, said Swaroop. Gene augmentation may be a viable therapy for LCA caused by other autosomal-dominant mutations.

This proof-of-concept gene therapy study is the first step toward a potential treatment for a rare form of LCA, said Brian Brooks, M.D., NEI clinical director and co-author on the study. Its a great example of bench-to-bedside science, when researchers in basic and clinical science collaborate.

The current study was funded through the intramural programs of the NEI and the National Institute of Allergy and Infectious Diseases, both part of NIH. Patient samples were collected at the NIH Clinical Center, clinical trial number NCT01432847.

NEI has protected intellectual property around this technology which is available for licensing and or co-development. Details can be found on the NIH OTT Licensing website: Gene Therapy for Treatment of CRX-Autosomal Dominant Retinopathies | Office of Technology Transfer, NIH or by contacting NEI Office of Translational Research mala.dutta@nih.gov

Additional authors include: Zepeng Qu, James Gentry, Benjamin Fadl, Linn Gieser, Suja Hiriyanna, Zacahry Batz, Mugdha Samant, Ananya Samanta, Colin Chu, Laura Campello, and Zhijian Wu.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Kruczek K. Qu Z, Gentry J, Fadl BR, Gieser L, Hiriyanna S, Batz Z, Samant M, Samanta A, Chu CJ, Campello L, Brooks BP, Wu Z, and Swaroop A. Gene therapy of dominantCRX-Leber congenital amaurosis using patient stem cell-derived retinal organoids.Stem Cell Reports, January 28, 2020.https://doi.org/10.1016/j.stemcr.2020.12.018

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Researchers use patients' cells to test gene therapy for rare eye disease - National Institutes of Health

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If you have cancer and your doctor recommends Opdivo to treat it, you may be wondering what side effects this drug might cause.

Opdivo (nivolumab) is a brand-name prescription medication used in adults to treat certain types of cancer. These include specific forms of bladder, colorectal, and esophageal cancer, as well as several other cancer types. Its also used in some children to treat colorectal cancer.

Opdivo is a biologic drug (a type of drug made from living cells). Specifically, its an immunotherapy treatment, which means it can cause side effects involving your immune system. Its given as an intravenous infusion (an injection into a vein thats given over a period of time). For more information about Opdivo, see this in-depth article.

Opdivo may be a long-term cancer treatment. Your doctor will decide the length of your treatment based on various factors, including what side effects you experience.

Read on to learn more about the possible mild and serious side effects of Opdivo.

Like all drugs, Opdivo may cause side effects in some people.

The more common side effects of Opdivo include:

For more information about rash as well as muscle, bone, and joint pain, see the Side effects explained section below.

Certain side effects may be more common if other cancer drugs, such as ipilimumab (Yervoy), are part of your treatment plan. You may have a higher risk for certain side effects depending on the type of cancer you have.

Talk with your doctor about your risk for side effects, given your specific treatment plan. Also tell them about any side effect symptoms you may have.

Learn more about Opdivos side effects in the next sections.

You may experience mild side effects with Opdivo, such as:

For more information about muscle, bone, and joint pain, see the Side effects explained section below.

Opdivo may cause mild side effects other than the ones listed above. See the Opdivo Medication Guide for details.

Opdivos mild side effects should be manageable, and theyll likely go away during your treatment. But some could also be signs of more serious side effects.

If any side effects bother you, get worse, or dont go away, talk with your doctor or pharmacist. Try to keep all of your appointments to get Opdivo unless your doctor stops your treatment.

Opdivo may cause serious side effects. While these are generally rare, some people may be at higher risk for certain serious side effects. For example, your risk for some side effects may increase if youre receiving both Opdivo and other drugs for your cancer.

Call your doctor right away if youre having any new or worsening symptoms. If your symptoms feel life threatening, call 911 or get emergency medical care right away.

Serious side effects can include:

For more information on hepatitis, type 1 diabetes, and allergic reaction, see the Side effects explained section below.

Talk with your doctor about your risk for serious side effects. Also let them know about any concerns you may have.

Get answers to some frequently asked questions about Opdivos side effects.

No, Opdivo shouldnt cause confusion. In clinical studies of Opdivo, confusion wasnt a reported side effect.

However, confusion may be a symptom of rare, serious side effects of Opdivo, such as:

Also, Opdivo can cause hyponatremia (low blood sodium levels). Confusion is a symptom of this condition, which was a common side effect in certain clinical studies of Opdivo.

If youre feeling disoriented or having trouble thinking clearly during Opdivo treatment, contact your doctor right away.

In clinical studies of Opdivo as a melanoma treatment, reported side effects were similar to those researchers found when looking at the drug to treat other cancers.

However, Opdivo isnt always used alone to treat melanoma. The risk of side effects may differ depending on your treatment plan. For more information, see the Opdivo Medication Guide.

If youre receiving Opdivo infusions to treat melanoma, ask your doctor about your side effect risks.

Side effects with Opdivo can happen at any time, including after stopping treatment.

For example, severe reactions have happened during Opdivo infusions. However, these are rare compared with mild or moderate infusion-related reactions. Some people have had reactions within 2 days after their infusion, although these are rare as well.

Opdivo may cause your immune system to attack healthy tissues or organs. This can happen anytime during or after stopping Opdivo treatment.

Symptoms of a severe reaction that may happen during an Opdivo infusion can include:

If you have these or other symptoms during an Opdivo infusion, immediately tell the healthcare provider who is giving you the infusion.

Though rare, people have had reactions up to 2 days after their infusion. You should watch for any new or bothersome symptoms on the days between your infusions, too.

If you have a severe reaction, your healthcare provider may stop your Opdivo infusion. If you have a mild or moderate reaction during your infusion, they may slow the rate of infusion or pause it to help manage your symptoms.

Yes, it can. For example, Opdivo treatment could increase your risk for pneumonia. Pneumonia is a serious infection of the air sacs in one or both of your lungs.

In clinical studies for certain cancers, pneumonia was one of the more common serious reactions when Opdivo was used alone or with the cancer drug ipilimumab (Yervoy).

In clinical studies for certain cancers, rare but fatal infections have also occurred when Opdivo was used alone or with other cancer drugs.

Upper respiratory tract infection, such as a cold, is a common side effect of Opdivo. Though upper respiratory tract infections arent usually serious, they can lead to secondary infections such as pneumonia.

See your doctor if you have any infection symptoms such as a cough, shortness of breath, or fever.

Learn more about some of the side effects Opdivo may cause.

You may have painful joints from treatment with Opdivo. Joint pain is a common side effect of the drug.

Muscle, back, and bone pain are also common side effects of Opdivo.

Opdivo can cause your immune system to attack healthy tissues, even after youve stopped the drug. This can happen to any part of your body, including your joints. Rarely, arthritis (swelling in your joints) has occurred with Opdivo treatment.

If youre experiencing pain in your joints or other areas of your body during or after Opdivo treatment, talk with your doctor. They can check your symptoms and suggest ways you can manage them.

For mild joint pain, they may recommend you take an over-the-counter pain reliever, such as ibuprofen (Advil or Motrin). They may also suggest applying ice packs or warm compresses to your joints.

Rash is a common side effect of Opdivo.

In rare cases, Opdivo may cause a severe skin reaction, such as Stevens-Johnson syndrome. It may also result in allergic reactions, which may be mild or serious. Rash can be a symptom of both of these reactions.

During and after Opdivo treatment, contact your doctor if you have a rash that bothers you, gets worse, or doesnt go away. Get emergency medical care right away if you have blisters, peeling skin, or rash accompanied by fever, swelling, or trouble breathing. These could be signs of a severe, life threatening reaction.

If your symptoms are mild to moderate, your doctor may suggest that you manage them with a topical cream or ointment, such as hydrocortisone cream.

If youre having a severe skin reaction, your healthcare provider will pause or permanently stop your Opdivo infusions. Theyll manage the reaction with corticosteroids, such as prednisone, or other immune-suppressing drugs.

Though rare, Opdivo treatment may cause your immune system to attack healthy tissues, including your liver. When this happens, it can cause inflammation (swelling and damage) of your liver known as hepatitis.

This side effect may be more likely to happen if your treatment plan includes both Opdivo and the cancer drug ipilimumab (Yervoy).

If you have hepatitis from Opdivo treatment, your healthcare provider will pause or permanently stop your infusions. Theyll manage the condition with a corticosteroid drug, such as prednisone. In some cases, you may need to take another immune-suppressing drug.

During and after stopping Opdivo treatment, tell your doctor if you have any symptoms of hepatitis, such as:

Rarely, Opdivo may cause type 1 diabetes. With type 1 diabetes, your blood glucose (sugar) level becomes too high because your pancreas isnt releasing insulin. If untreated, this can lead to serious complications. An example is diabetic ketoacidosis (high levels of blood acids called ketones), which can be fatal.

Your doctor may check your blood glucose level while youre getting Opdivo. During and after your treatment, watch for any diabetes or ketoacidosis symptoms, such as:

Remember, high blood glucose can cause severe complications. If you have any of the symptoms listed above, see your doctor or get medical care right away.

Like most drugs, Opdivo can cause an allergic reaction in some people. Symptoms can be mild or serious and can include:

For mild symptoms of an allergic reaction, such as a mild skin rash or itching, call your doctor right away. They may suggest an over-the-counter oral antihistamine, such as diphenhydramine (Benadryl), or a topical product, like hydrocortisone cream, to manage your allergic reaction.

If your doctor confirms you had a mild allergic reaction to Opdivo, theyll decide if you should continue receiving this drug.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you had a serious allergic reaction to Opdivo, theyll stop your Opdivo treatment and decide if another cancer treatment is right for you.

During your Opdivo treatment, consider keeping notes on any side effects youre having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things like:

Sharing such notes with your doctor will help your doctor learn more about how Opdivo affects you. Your doctor can also use this information to adjust your treatment plan if needed.

Opdivo may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before starting Opdivo. Factors to consider include those mentioned below.

Stem cell or organ transplant. Opdivo treatment before or after an allogenic hematopoietic stem cell transplant (transplant of blood-forming cells from a genetic match) could cause serious or fatal problems.

If youre planning a stem cell transplant or have had one, talk with your doctor about the safety of Opdivo treatment. Also tell your doctor if youve received an organ transplant.

Allergic reaction. If youve had an allergic reaction to Opdivo or any of its ingredients, Opdivo shouldnt be part of your cancer treatment. Ask your doctor what other medications are better options for you.

Immune system problems. With Opdivo treatment, your immune system may attack healthy tissues.

Before starting Opdivo, tell your doctor if you have an autoimmune or inflammatory condition, such as Crohns disease, ulcerative colitis, or lupus. Tell them even if your condition is in remission (times when youre symptom-free).

History of chest radiation. Opdivo may cause a serious side effect of the lungs called pneumonitis. Your risk for pneumonitis may be higher if youve had radiation treatment to your chest.

Before starting Opdivo, tell your doctor about any past chest radiation treatments youve had and if youve received other drugs similar to Opdivo.

Nervous system problems. In rare cases, Opdivo treatment may cause your immune system to attack your nervous system, including your brain, spinal cord, or nerves.

Before starting Opdivo, tell your doctor if youve had a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barr syndrome.

Opdivo doesnt interact with alcohol.

However, alcohol can harm your liver. In rare cases, Opdivo can cause inflammation (swelling and damage) of your liver known as hepatitis. Opdivo can be used to treat some liver cancers.

Ask your doctor if its safe to consume alcohol while being treated with Opdivo.

Its unsafe to be treated with Opdivo during pregnancy. If youre able to become pregnant, youll need to get a pregnancy test before starting Opdivo to make sure youre not pregnant.

Youll also need to use effective birth control during treatment and for at least 5 months after your last infusion.

Opdivos manufacturer hasnt given recommendations about contraception for people taking Opdivo who have a partner who can become pregnant. If you have questions or concerns about this, talk with your doctor.

Its unknown if Opdivo is safe to use while breastfeeding. You shouldnt breastfeed during Opdivo treatment or for at least 5 months after your last infusion.

Before starting Opdivo, talk with your doctor about safe ways to feed your child.

Opdivo may help treat your type of cancer. At the same time, it can put you at risk for rare but serious side effects. However, most common symptoms of Opdivo are mild or manageable.

If youre wondering about Opdivos side effects, talk with your doctor or pharmacist. Ask questions to get the answers you need to feel confident about your cancer treatment. Here are a few to get you started:

My doctor said thyroid problems are possible serious side effects of Opdivo. What symptoms should I watch for?

Opdivo may cause your immune system to attack your thyroid gland, resulting in thyroiditis (inflammation of the thyroid gland). Though thyroiditis isnt usually serious, it can lead to hypothyroidism (low thyroid levels) or hyperthyroidism (high thyroid levels).

Hypothyroidism may happen more often, especially when Opdivo is used with ipilimumab (Yervoy).

Symptoms of hypothyroidism include increased weight, fatigue (lack of energy), and feeling cold. They also include a slow heart rate, depression, and a puffy face.

Symptoms of hyperthyroidism include a fast heart rate, high blood pressure, shaking hands, and trouble sleeping.

Call your doctor if you have any of the above symptoms. They may pause or stop your Opdivo treatment depending on how severe the side effect is. Your doctor may also recommend that you take other medication to treat your hypothyroidism or hyperthyroidism.

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Opdivo Side Effects: What They Are and How to Manage Them - Healthline

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Scientists have identified a protein that can slow or stop some signs of Parkinsons disease in mice.

The team found that the bone morphogenetic proteins 5 and 7 (BMP5/7) can have these effects in a mouse model of the disease.

This research, which appears in the journal Brain, may be the first step toward developing a new treatment for Parkinsons disease.

This type of brain disorder typically affects people over the age of 60, and the symptoms worsen with time.

Common symptoms include stiffness, difficulty walking, tremors, and trouble with balance and coordination.

The disease can also affect the ability to speak and lead to mood changes, tiredness, and memory loss.

Parkinsons Foundation report that about 1 million people in the United States had the disease in 2020, with about 10 million affected globally.

Despite this prevalence, scientists are still unsure why Parkinsons disease affects some people and not others, and there is currently no cure.

The National Institute on Aging note that some cases of Parkinsons disease seem to be hereditary. In other words, the disease can emerge in different generations of a family but for many people with the disease, there appears to be no family history.

Researchers believe that multiple factors may affect a persons risk, including genetics, exposure to environmental toxins, and age.

Since there is currently no cure for Parkinsons disease, treatments typically focus on alleviating its symptoms.

Existing treatments can help alleviate of Parkinsons disease, such as stiffness. However, they may work less well, or not work, for others, such as tremors or a loss of coordination.

Though researchers are still unsure why some develop the disease and others do not, they understand what occurs in the brain of a person with Parkinsons.

The disease causes the neurons in the part of the brain that controls movement to stop working or die. The brain region, therefore, produces less of the chemical dopamine, which helps a person maintain smooth, purposeful movement, as the National Institute of Neurological Disorders and Stroke observe.

Also, Lewy bodies occur in the brains of some people with Parkinsons disease. These bodies are clumps primarily made up of misfolded forms of the protein alpha-synuclein.

In their recent study paper, the scientists refer to research suggesting that neurotrophic factors molecules that help neurons survive and thrive could, in theory, restore the function of neurons that produce dopamine. However, the clinical benefit of these factors had yet to be proven.

The team focused on bone morphogenetic proteins 5 and 7 (BMP5/7). They had previously shown that BMP5/7 has an important role in dopamine-producing neurons in mice.

In the latest study, the scientists wanted to see whether BMP5/7 could protect the neurons of mice against the damaging effects of misfolded alpha-synuclein proteins.

To do this, they injected one group of mice with a viral vector that caused misfolded alpha-synuclein proteins to form in their brains. They used other mice as a control group. The scientists then injected the mice with the BMP5/7 protein.

The researchers found that the BMP5/7 protein had a significant protective effect against the misfolded alpha-synuclein proteins.

According to senior study author Dr. Claude Brodski, of the Israel-based Ben-Gurion University of the Negevs Department of Physiology and Cell Biology, We found that BMP5/7 treatment can, in a Parkinsons disease mouse model, efficiently prevent movement impairments caused by the accumulation of alpha-synuclein and reverse the loss of dopamine-producing brain cells. He continues:

These findings are very promising, since they suggest that BMP5/7 could slow or stop Parkinsons disease progression. Currently, we are focusing all our efforts on bringing our discovery closer to clinical application.

The universitys technology transfer company, BGN Technologies, is currently looking to bring the development to the market.

Dr. Galit Mazooz-Perlmuter, the companys senior vice president of bio-pharma business development, notes that There is a vast need for new therapies to treat Parkinsons disease, especially in advanced stages of the disease.

Dr. Brodskis findings, although still in their early stages, offer a disease-modified drug target that will address this devastating condition. We are now seeking an industry partner for further development of this patent-pending invention.

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Protein identified that may help treat Parkinsons disease - Medical News Today

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Lets get into the science behind it: As hair is being formed, melanocytes inject pigment into keratinocytesthe cells containing keratinwhich is the protein making up hair, skin and nails, says Wayne, NJ plastic surgeon and hair specialist Jeffrey B. Wise, MD. Over time, melanocytes continue to inject pigment into the hairs keratin, which is where hair gets its color. In the aging process, melanocytes slow down and eventually stop secreting melanin, which causes a lack of pigment, and the hair turns gray.

According to Chicago dermatologist Dr. Quenby Erickson, going gray is programmed in our genetic code, which means we can get clues as to how extensively and when it will happen by looking at our parents. However, a 2020 study published in Science Daily shows there may also be a link between stress and gray hair. When testing on mice, researchers found that the type of nerve involved in the fight-or-flight response causes permanent damage to the pigment-regenerating stem cells in the hair follicle. The study makes perfect sense, says Dr. Wise. Stress is a huge factor in premature aging, as well as hair thinning. Naturally, it should also affect hair graying as well. There is also a lot of evidence that shows smoking cigarettes plays a role in making hair go gray earlier.

Color isnt always the only factor either; textural changes can ensue as well. Some people are blessed with gorgeous gray hair, but for most of us, the gray is accompanied with thinning and rougher texture that leave our hair finer and harder to style, Dr. Erickson says. There are no proven ways to prevent hair from turning gray, but both Drs. Erickson and Wise have seen some promising results from platelet-rich plasma (PRP) injections. Because these treatments are aimed at waking up your own stem cells, they could potentially reinvigorate melanocyte production as well, explains Dr. Wise. We have seen growth of darker, thicker hairs on some of our stem cell therapy patients, even though the original goal was to combat thinning. Treatment results are dependent on the patients individual conditions, so realistic expectations should be set by your doctor.

Celebrity colorists Chad Kenyon and Rita Hazan say none of their clients embraced their grays during quarantine, or they tried, but caved eventually. For those in camp cover them up, topical dyes and root concealers can help camouflage. The process to cover gray hair is the same on both blonds and darker shades, but my clients with lighter hair can go longer in between touch-ups because gray hairs blend with blond hairs more easily, says Kenyon. Celebrity colorist Aura Friedman often suggests adding a darker pepper tone to silver hair for people who feel more comfortable being darker, but dont want the two-, three- or four-week regrowth touch-up thats needed.

For those who want to permanently cover their grays at home, Nikki Lee, celebrity colorist and cofounder of Nine Zero One Salon, recommends Garnier Nutrisse Nourishing Color Creme ($8). There are more than 75 shades and you can easily find your match using a virtual shade selector, she says. If DIY color makes you nervous, temporary root sprays are great to use in between salon appointments.

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Why Hair Goes Gray, and How to Cover It If You Want To - NewBeauty Magazine

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The International Society for Stem Cell Research (ISSCR) will present this years ISSCR Momentum Award to Valentina Greco, PhD, Carolyn Walch Slayman Professor of Genetics and member of the Yale Stem Cell Center. The prize recognizes the exceptional achievements of an investigator whose innovative research has established a major area of stem cell-related research with a strong trajectory for future success. Greco will present her science during a special lecture on June 25 during ISSCR 2021 Virtual, the worlds leading meeting of global innovators in stem cell science and regenerative medicine.

Studies from Grecos lab are redefining scientific understanding of the complex mechanisms that organize and regulate the skin stem cell niche and the behavior of normal and mutant cells in the epidermis under physiologic challenge and with aging. Her groups body of work exploring cell biology in vivo determined that the niche, rather than the stem cells, are required for tissue growth, that location in the niche dictates stem cell fate, that the niche exploits stem cell plasticity to maintain homeostasis, and that homeostatic correction battles disease emergence. These breakthroughs pave the way for new concepts in mammalian regenerative biology.

Valentina is a wonderful ambassador for the stem cell community and in particular for young, female scientists in our field, said Christine Mummery, PhD, ISSCRs president. She has a confidence and skill to pursue bold new ideas. Not only is she a pioneer in live cell imaging, but she also has made multiple important discoveries regarding the mechanisms that regulate epithelial stem cell function. We are honored to recognize Valentina for her momentous achievements.

Beyond her creativity and scientific talent, Greco has shown great leadership. She is deliberate in her commitment to career development and the training of young faculty and her lab members, and brings tremendous enthusiasm to her work. Throughout her career, Greco has sought out new ways to enhance her effectiveness as a mentor by pursuing education from others, thereby establishing a strong foundation for making fundamental scientific discoveries in partnership with her lab members. She shared her perspectives and experiences as a woman and an immigrant working in science in Stem Cell Reports, Women in Stem Cell Science, Part 1.

My lab and I are honored to be recognized with this award, Greco said. Our science is inspired by the previous insights of incredible scientists that have paved the way for our contributions including the inspiring work of Cristina Lo Celso, David Scadden, Charles Lin, and Shosei Yoshida and their pioneering live imaging of mammalian stem cells in blood regeneration and spermatogenesis.

Greco was also awarded the ISSCR Dr. Susan Lim Outstanding Young Investigator Award in 2014.

Submitted by Robert Forman on January 25, 2021

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Valentina Greco Receives the 2021 ISSCR Momentum Award < Yale School of Medicine - Yale School of Medicine

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CENTENNIAL, Colo., Jan. 26, 2021 /PRNewswire/ --Essent Biologics, a nonprofit biotechnology company emerging from two years of stealth-mode operation, today announced its launch as a new venture to meet the growing need for human-derived biomaterials and data to the regenerative medicine research community, as well as producing key inputs for further manufacturing by clinical partners.

As a new venture from AlloSource, one of the world's leading manufacturers of fresh cartilage tissue used for joint repair and skin allografts to heal severe burns, Essent Biologics will leverage its connection to human tissue donation by providing low passaged primary cell lines, origin tissue and comprehensive donor data to advance translational research from benchtop to bedside. The company also has the capability to serve as a biomanufacturing partner, creating a large inventory of custom products.

"We are proud to set a new standard in human-derived biomaterials for research," said Corey Stone, Executive Director, Essent Biologics. "Essent will motivate and empower the work researchers are doing by supporting the development of innovative therapies through quality biomaterials and powerful data."

Essent Biologics will supply highly characterized human mesenchymal stem cells (MSCs) produced under current Good Manufacturing Practices (cGMP). The company has already partnered with leading academic research and biopharmaceutical companies who excitedly await Essent Biologics' official product launch, anticipated in April.For additional information on the company's product pipeline, please visit essentbiologics.org.

"The work Essent is doing to help accelerate research through human clinical trials is remarkable," said Ethan Mann, CEO of Validus Cellular Therapeutics, Inc. "We are excited to partner with such an innovative company who will support research to develop new medical solutions, and we look forward to their future growth."

According to Allied Market Research, the Cellular Therapy and Tissue Engineering industries are some of the fastest growing in the regenerative medicine sector. The Cellular Therapy market tallied a total expenditure of $7.25 billion in 2019 and is expected to hit $48.11 billion by 2027. The Tissue Engineering market tallied a total expenditure of $2.3 billion in 2019 and is expected to hit $6.8 billion by 2027. These strong growth rates are powered by an increase in clinical trials and manufacturing throughput.

About Essent BiologicsEssent Biologics is setting a new standard in human-derived biomaterials and 3D biology data for research. The nonprofit biotechnology company provides low passaged primary cells, origin tissue and scaffolds, as well as comprehensive donor and product data to advance regenerative medicine research from benchtop to bedside. Essent Biologics supplies products in small or large volumes and serves as a manufacturing partner by creating master cell banks and an inventory of custom products within a tailored specification. In order to ensure reliable product quality, safety and efficacy, all Essent Biologics products are developed using robust design control processes and produced under current Good Manufacturing Practices (cGMP). For more information, please visit essentbiologics.org.

Media ContactCorey StoneEssent Biologics720.873.4781cstone@essentbiologics.org

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Essent Biologics Launches With A Mission To Provide Human-Derived Biomaterials And 3D Biology Data For Cell Therapy And Tissue Engineering - The Grand...

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Unfortunately, there arent too many manatees that dont have a wound, says Jon (JP) Peterson, vice president of zoological operations at SeaWorld in Orlando, Fla. Peterson oversees the rescue team, a group of wildlife veterinarians and animal specialists who travel the coastal waterways of the Southeast providing emergency medicine to wild animals, including injured, cold and orphaned manatees. Boats are the most common cause of wounds: Sharp skegs and propellers scrape along the animals backs and flanks, leaving behind everything from minor scratches to much more severe lacerations like those Peterson calls sucking chest wounds.

Assess the cut and nearby tissue. Gray is bad, Peterson says. You want pink. If you see dark gray or brown, blood, pus or smell a pungent odor, there is usually infection. A manatees outer skin is tough, like an elephants hide, and prone to close up quickly. Clean, flush and scrub the wound with a sterile solution like chlorhexidine until youve removed the necrotic tissue (you may need to cut it out). To accelerate healing, Petersons team uses antibiotics, cold-laser therapy and stem cells, as well as raw, unpasteurized honey. Use a tongue depressor and pack the honey into the wound, Peterson says. With its sticky, antibacterial properties, honey stays put, even underwater.

Dont underestimate the strength of these animals. Theyre one ball of muscle, Peterson says. Dolphins and whales make less challenging patients. Release healed manatees back into the wild. Of course, unless youre trained and permitted by the U.S. Fish and Wildlife Service, you should not handle manatees at all. Mistreating them is illegal and can result in a fine and prison time. In 1967, only a few hundred manatees remained in Florida when they were listed among the first class of endangered species under the Endangered Species Act. Researchers now estimate the population at 6,300, most with crisscrossing bright white scars across their bodies. In fact, scarring is so prevalent that scientists use scar patterns to identify individual manatees during aerial surveys. You can look down from an airplane and see, Oh, look, theres so-and-so, Peterson says.

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How to Treat a Wounded Manatee - The New York Times

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There are lots of places in a skincare routine where a budget product can do the job perfectly well, but your serum often isnt one of them; an effective, affordable serum is a rare thing. Its no wonder, then, that a bottle of The Body Shops brilliant youth concentrate sells every 27 seconds.

The entire Drops of Youth range, of which youth concentrate is one of the stars, is formulated around the same quad of ingredients and, as well as the serum, includes a foaming cleanser, toner, eye cream, moisturiser, night-time mask, sheet mask, reformulated liquid peel and the new bouncy jelly mist.

As part of its launch, a trio of products from the Drops of Youth range the new mist, the reformulated peel and the cult serum have been rebranded for the lockdown age, emphasising their pollution clearing and blue light-fighting properties.

Now we are spending more time indoors than ever, you might expect that our skins exposure to environmental damage is much reduced. But indoor pollution is a problem, too. Confined to our houses, heating, ventilation, cooking, damp, dust and even the light from your phone have the potential to cause surface-level congestion (aka spots) and deep damage, leading to premature ageing and possible discolouration.

High-energy visible light (HEV light), often referred to as blue light are rays emitted from the screens of the devices phones, tablets, laptops on which we increasingly spend our days, and penetrates the skin more deeply than UV rays, in part due to how much closer its source is to our faces than the sun.

We put the new and improved range to the test to see if it lives up to expectations.

You can trust our independent reviews. We may earn commission from some of the retailers, but we never allow this to influence selections, which are formed from real-world testing and expert advice. This revenue helps to fund journalism across The Independent.

Drops of Youth Bouncy Jelly Mist

(The Body Shop)

The Drops of Youth bouncy jelly mist feels wetter and more substantial on first application than many similar hydrating sprays, and quickly absorbs and dries down to a silky, matte finish on the skin. We love it for a mid-afternoon refresh, when our skin is starting to feel dry, though we find the spritz a little too heavy to apply directly to the face, and so prefer to spray it into our hands first. If you want to spray it over make-up, make sure you hold the bottle an arms length away.

The formula contains a trio of plant stem cells: criste marine, sea holly and edelweiss, all of which are known for their resilience and regenerating powers in the wild. Edelweiss, sourced from the Italian Alps, is particularly interesting. The flower survives UV rays and extreme weather where it grows at altitude, and in skincare is a powerful antioxidant.

It contains leontopodic acid, which strengthens the skins barrier, encouraging regeneration and hydration, and reducing and soothing sensitive reactions, thus increasing your skins resistance to external pressures including blue light and indoor pollution.

It also contains fair trade moringa oil, which is itself an excellent source of vitamins and antioxidants, including quercetin and vitamins A, C and E, all of which further the protection against environmental aggressors offered by the Drops of Youth plant stem cell trio. Moringa oil is also a good source of amino acids and oleic acid, a fatty acid that helps restore the skins natural barrier and protects against moisture loss, and is a lighter weight than many other plant oils. Youll find all these ingredients throughout the Drops of Youth range, making it a strong offering for both antioxidant protection and lasting hydration.

(The Body Shop)

The cult youth concentrate serum is, of course, also a favourite. With its pipette applicator, slightly gloopy texture and excellent slip across the skin (a tiny drop goes a long way), it has the application experience of a far more expensive serum. It dries to a slightly tacky finish (which we dont mind, as its rarely the final product in our routine) and feels like a fresh drink for your skin. For those who want a hydrating, protecting serum, it makes a happy two-in-one swap for hyaluronic acid and vitamin C serums, and at a very competitive price point.

Drops of Youth Liquid Peel

(The Body Shop)

Completing the trio is the liquid peel, which has a gel-like consistency and is, curiously, massaged into dry skin. After a few seconds white peelings begin to lift away from the skin; it's quite a dramatic effect and the claim is that this is dead skin lifting away, but at least some of it will be the product itself.

The classic exfoliating ingredient in the peel is citric acid, though it's very low on the ingredients list, meaning it's included in small quantities. Skin is left soft and smooth, and it's a good option for those with sensitive skin or who are scared of the exfoliating heavyweights, but those who are after a more serious peel will find it underwhelming.

Drops Of Youth Eye Concentrate

(The Body Shop)

Another highlight from the range, this has a rolling metal ball applicator and a light, gel-like texture that is more like a serum than a traditional eye cream. It is gorgeously soothing and cooling perfect on tired, irritated eyes and to alleviate morning puffiness and leaves the skin plumped and smooth.

We also love the youth cream moisturiser (25), which again has a light, whipped gel texture and leaves skin plump and silky smooth. Its the perfect base for make-up.

Drops of Youth bouncy sleeping mask

(The Body Shop)

A final favourite is the youth bouncy sleeping mask (22), and not just for the name. We love the promise of night skincare maximum time for the product to work on its skin, minimum effort involved and this is a proper mask that requires rinsing off in the morning, unlike many night-time masks, which feel more like heavy moisturisers. It has a thick, jelly-like texture that you have to really dig into to break the surface; after each unceremonious scoop it magically settles into a smooth, level surface infinitely satisfying. Skin is left brighter, nourished and glowing in the morning.

The verdict: The Body Shop Drops of Youth range

The range is a brilliant choice for skincare addicts after protection from environmental damage and bouncy, hydrated skin without the spend demanded by luxury products. The cult serum, youth concentrate, remains the star of the extended line-up, but your face will reward you for adding the new bouncy jelly mist to your cart, too. Drops of Youth is a bold marketing claim, but the plump, fresh, glowing skin it gives certainly helps.

IndyBest product reviews are unbiased, independent advice you can trust. On some occasions, we earn revenue if you click the links and buy the products, but we never allow this to bias our coverage. The reviews are compiled through a mix of expert opinion and real-world testing.

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We tried The Body Shops new Drops of Youth skincare range heres what we thought - The Independent

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