Most of us are familiar with the scientific fact that any living, breathing animal, insect etc. is made up of cells. These cells form tissues and organs that support the existence of the host. Many of us have also heard of stem cells therapy for autism but are unsure about its validity.

Scientists have studied the underlying mechanism of cells, as well as their functioning, and have discovered ways of using the cells to improve the lives of humans and treat diseases. To do so, scientists have discovered stem cells; think of it as the building blocks of a fully differentiated cell.

Stem cells are human cells that can be developed and differentiated into other cell types. These cells can be derived from any part of the body, for example, stem cells from the brain, muscle, bone marrow, etc. Stem cells are versatile in that they can be used to fix damaged tissues. The two essential characteristics of stem cells include: Firstly, the ability to self-renew to create successors identical to the original cell. Secondly, stem cells, unlike cancer cells, are controlled and highly regulated, therefore, stem cells need to be able to give rise to specialized cell types that become part of the healthy body.

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The purpose of stem cell therapy is to regenerate and repair damaged tissues and cells in the body. There are two main classes of stem cells. Pluripotent stem cells have the potential to become any cell in the adult body and multipotent stem cells are much more restricted to a specific population or lineage of cells. Other stem cell types include totipotent and unipotent.

Lets look at pluripotent and multipotent stem cells in detail.

Pluripotent stem cells are generated from somatic cells. These mainly come from embryos and, as such, theyre often referred to as embryonic stem cells.

Lets discuss three types of embryonic stem cells that are used to generate pluripotent cells. These include true embryonic stem cells (ES), nuclear transfer of somatic cells (ntES), and parthenogenetic embryonic stem cells (these are stem cells from unfertilized eggs).

The true embryonic stem cells are made from unused embryos, such as those that undergo IVF (in vitro fertilization). The process of IVF is such that the eggs and sperm are fertilized in a lab dish. What then happens is that, through this process, more embryos are generated, usually more than the couple actually need. Those that arent used can be donated to science.

Pluripotent cells made from these unused embryos are not genetically matched to the original hosts. These are mainly used in science for studies to learn how stem cells regenerate.

Every cell contains an organelle called a nucleus. The nucleus contains all the cells genetic information essential to its function. The word somatic refers to any cell in the body.

The process of somatic cell nuclear transfer (SCNT) extracts the nucleus from a somatic cell and transfers it into another cell that has had its own nucleus removed; i.e. the nucleus from the previous cell is being transferred to an egg cell that does not contain a nucleus (unnucleated).

When the nucleus is transferred to another cell, it activates the process of pluripotent cell generation that reprograms the generation of genes in that cell. The egg then becomes a zygote nucleus or a fertilized egg, the cell then replicates and through it embryonic stem cells are created.

Imagine being able to fertilize an egg without fertilization by sperm. Unusual, but science makes crazy things happen.

Parthenogenesis is the process whereby an unfertilized egg develops an embryo without fertilization. This can be achieved through chemical, physical or combined activation methods.

The parthenogenetic embryonic stem cells have the capacity for infinite proliferation and self-renewal, and maintain the ability to differentiate into one or more specialized types of cell or tissue.

pESCs are especially useful for regenerative medicine, and therefore allow the generation of functional cells that could potentially be used as treatment for many incurable diseases in the future.

Multipotent stem cells are unspecialized cell types that have the ability to self-renew and differentiate into specialized cell types. However, these cells are specific to the type of tissue or organ. For example, a multipotent adult stem cell from the bone marrow can become specialized to produce all blood cell types; and cells in the stem cells from neural networks in the brain can specialize to glial and neuronal cells.

When we talk about all blood cell types, we have to get a little scientific, but for the curious mind, all blood cell types refers to platelets, B and T lymphocytes, natural killer cells, dendritic cells.the list goes on.

In addition, for the curious mind, various types of stem cells include hematopoietic stem cells (the ones that make blood cell types), mesenchymal stem cells (differentiate into bone, fat, cartilage, muscle, and skin), and neural stem cells (from neural networks).

Now that weve covered the types of stem cells, the question remains, can stem cell therapy cure autism? Lets have a look.

To answer this question, I refer to the review by Price (2020) as it is the latest up-date data on this subject. It is important to note however, that at the time of reading this article there may be other research data published on this topic.

Several research studies cite immune dysfunction as the cause and effect of autism spectrum disorder (ASD). By virtue of this analogy, it has informed the basis of the stem cell therapy approach for treating autism. This is founded on the properties that regulate the immune system (immuno-regulatory properties).

From the review, it was also found that when exposed to inflammatory stimuli, this may lead to the development of postnatal diagnosis of ASD. Inflammation to the cell describes the process that occurs when the cell is exposed to harmful stimuli such as bacteria, trauma, toxins, heat, and pathogens. The affected cells then release chemicals that cause blood vessels to leak fluid into the tissues, causing swelling.

Therefore, an inflammatory stimuli is that which influences the occurrence of an inflammatory response.

Other bodies of research found an altered level of proteins called cytokines which are essential for interaction and communication between cells in ASD. These may also be the cause of the development of autism spectrum disorder. Some genetic studies propose an association between a genetic loci (a specific point on the genome of the autistic individual) and ASD whose function is related to immune function. While others suggest a possible anomaly in the neuronal signaling pathway that directs communication and information transfer between neurons

All these are proposed reasons that hypothesize the use of stem cell therapy to treat autism biologically. However, all these propositions do not lead to one voice, there are too many hypotheses that make it difficult to narrow down the target area that would potentially treat autism or autism symptoms. Keeping in mind that autism traits are diverse, therefore, narrowing this information down to one plausible pathology is an even greater challenge.

So, is stem cell therapy effective? The answer to this is unknown.

Is ASD caused by genetic, immune dysfunction, or inflammatory stimuli? The answer to this is not clear and theres a vast number of studies that argue different theories.

It is even more disturbing to consider these hypotheses because, for example, each person can experience bacterial or viral infections, or stress that can impact immune functioning and/or lead to inflammation but were not all on the spectrum. Therefore, we cant say that factors which alter our immune functioning lead to the development of neurodevelopmental conditions.

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However, according to Price, the study by Riordan et al. (2019) proposes the influence of cytokines for the treatment of autism.The data proposed could be a point in a positive direction to answering whether stem cell therapy could potentially treat autism symptoms.

Unfortunately, there is no data to positively state the effectiveness of stem cell therapy for treating autism. As more research is developed in this field, theres hope that more understanding of autism will arise, and perhaps an alternative form of treatment of autism symptoms can be developed. It is also worth noting the possibility of genetic markers that could help diagnose autism during pregnancy or during the prenatal development stage.

The studies highlighted in this article are simply preliminary assessments. Further research needs to be conducted in order to understand the potential of cell therapies for treating autism.

The findings of these studies vary in hypothesis and this makes generalization hard. Science has developed greatly over years, therefore, for those that believe in the potential of science and all that it could offer, theres a reason to hope that stem cell therapy could potentially be used as treatment for autism in the near future.

Biehl, J. K., & Russell, B. (2009). Introduction to stem cell therapy. The Journal of cardiovascular nursing, 24(2), 98105. https://doi.org/10.1097/JCN.0b013e318197a6a5

Price, J.(2020). Cell therapy approaches to autism: a review of clinical trial data. Molecular Autism, 11, 37 . https://doi.org/10.1186/s13229-020-00348-z

http://stemcell.childrenshospital.org/about-stem-cells/adult-somatic-stem-cells-101/where-do-we-get-adult-stem-cells/

Thermo Fisher Scientific. An Overview of Pluripotent and Multipotent Stem Cell Targets. https://www.thermofisher.com/za/en/home/life-science/antibodies/antibodies-learning-center/antibodies-resource-library/antibody-methods/pluripotent-multipotent-stem-cell-targets.html

Yu, Z., Han, B. (2016). Advantages and limitations of the parthenogenetic embryonic stem cells in cell therapy. Journal of Reproduction and Contraception, 27 (2), Issue 2, 118-124. https://doi.org/10.7669/j.issn.1001-7844.2016.02.0118

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Stem Cells Therapy for Autism: Does it Work?

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Figure 2.. CD39 - CD69 - CD8 + TILs in infusion product are in a

(A) t-SNE plot of all CD8+ TILs from CR and NR I.P. (5 CRs, 5 NRs). (B) Frequency distribution of each cluster (1 through 8) expressed as a % of total CD8+ T cells in the I.P. for each patient. (C) Data points representing % of S.Cluster.A (top) and % of S.Cluster.B (bottom) per each patient I.P. between CRs and NRs. S.Cluster.A encompasses clusters C0, C2, C5, C6, and C7; S.Cluster.B comprises clusters C1, C3, C4, and C8. P-values by two-sided Wilcoxon rank-sum test are shown. (D) Heatmap of top 15 discriminating genes between S.Cluster.A and S.Cluster.B displayed for each cell. All discriminating genes are listed in Table S4. (E) t-SNE plot of clustered cells displayed by the top two quartiles of CD39-CD69- (DN) gene signature expression, and top two quartiles of CD39+CD69+ (DP) gene signature expression. (F) Each patient I.P. was scored by DN and DP gene signature scores and their mean scGSEA values are plotted. CRs are in red, and NRs are in black. P-values by two-sided Wilcoxon rank-sum test comparing the mean DN and DP signature scores between CRs and NRs are shown. (G) Flow cytometric analysis of inhibitory and memory markers within each subset (DN [CD39-CD69-], SP [CD39-CD69+, CD39+CD69-] and DP [CD39+CD69+] of patient I.P. in the validation set (n=38) expressed as % of each subset (parent gate). * P < 0.05 **P < 0.01 ***P < 0.001 ****P < 0.0001 by Tukeys multiple comparison test. (H) Flow cytometry of intracellular TCF7 expression for DN and DP subsets showing representative patient I.P. sample (top) and quantitation for 18 I.P. (bottom). P-value by two-sided Wilcoxon rank-sum test is shown. (I) Phenotypes of DN, SP, and DP states before and after CD3/CD28 stimulation at 48 hours showing flow cytometry plot in a representative patient sample (left) and summary of daughter cells in each state after stimulation of 6 patient I.P. (right). ***P < 0.001 by two-sided Wilcoxon rank-sum test. (J) t-SNE clusters of CD8+ TILs from Melanoma ICB cohort (15) (K) t-SNE plot colored by top two quartiles of DN and DP gene signatures, DN: red, DP: black (L) TILs from pre ICB therapy were scored by the top DN and DP gene signature scores and mean scGSEA scores are plotted. Cells from responding lesions are in red, and cells from progressing lesions are in black. Cell numbers and P-values by two-sided Wilcoxon rank-sum test are shown. (M) Clustered correlation matrix of gene signatures from other studies (Table S5) along with DN and DP scGSEA scores on pre-ICB cells from the cohort.

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Looking for that bright-eyed look? Here you go!

If there's one overlooked aspect of a persons skincare routine, it is moisturising the under eyes. The middle child of the skin care routine, oftentimes applying this product is overlooked for a full coverage concealer. Your deepening dark circles aren't thanking you for those sleepless nights spent binge watching your favourite comfort shows after a long, hard day at work. Eye creams are your best friend when it comes to wanting to look like you have your life together the next day at 9 am in the office. From depuffing to helping fade dark circles, fine line reduction and hydrating the delicate skin of your under eye, you name it, these products do it!

The Dear, Klairs Fundamental Nourishing Butter provides the essential moisture needed for the under eye and special antioxidant care for those battling dryness. So you can bid a happy adieu to fine lines and dark circles while also boosting the inherent elasticity of your skin. As its name rightfully suggests, its soft butter-like consistency easily absorbs into the skin to moisturise and brighten the under eyes. With the goodness of Vitamin A and E,quad peptide as well as sunflower seed oil to protect the delicate skin of our eyes, this nourishing eye butter goes well under your makeup giving you a smooth base like no other. Additionally, this cream can also be applied on the neck and nasolabial folds to reduce the appearance of fine lines.

Avocado in your smoothies, salads, face packs and now once again the glorious avocado in your eye cream. An eye cream with potent ingredients for skin that is dehydrated. The Kiehls Creamy Eye Treatment with Avocado is an excellent choice to give your skin radiance and make your eyes appear more alert. Shea Butter, Avocado Oil, and Beta-Carotene, a naturally derived antioxidant that is found in carrots and oranges and is known to sharpen the eye sight ,are used in its formulation to keep your skin moisturised and hydrated all day. These substances' qualities also combat ageing symptoms including wrinkles and fine lines. Excellent for all skin types!

The Innisfree Black Tea Youth Enhancing Eye Serum is a powerful product that reduces fine lines and wrinkles and camouflages signs of fatigue around the eyes. The serum emulsifies active components into the skin to nourish it back to health. With a brownie point earned for no stickiness left, it is brightening and highly nourishing in its make up. The exclusive innisfree green tea ( formulated after intense research) is fermented to make the star ingredient of this product the black tea. The Black Tea is then steeped in mineral water for 12 hours to extract all of the potent antioxidants and anti-aging ingredients. Reset Concentrate, a powerful active component, was produced using this exclusive extraction technique.

The Daughter Earth microemulsion under eye serum is a power packed eye serum that incorporates the Ayurvedic Super Triad- amalaki, haritaki and bibhitaki, popularly known as Triphala. Using modern scientific breakthrough apple stem cell technology and probiotics, this under eye serum will moisturise and nourish the sensitive skin of your undereyes with 8 Super Fruits, 5 Peptides, 3 Ceramides and 8 Amino Acids in a lightweight and potent formula. Its ingredients are tailor made to give you the most benefit. Caffeine, Quinoa and the skin loving ingredient niacinamide work towards eradicating dark circles and depuffing the eyes. Plant stem cells reduce fine lines and peptides and wild roselle make your skin supple and firm.

Enriched with the power of Anise, the Forest Essentials Intensive Eye Cream incorporates an Innovative formulation created especially for the delicate eye area. Papaya and potato starch active extracts aid in minimising the appearance of dry and dehydrated lines. It reduces the stubborn appearance of dark circles, fine lines, and dull skin. Along with sweet, cold pressed almond oil that deeply moisturises and adds a glow to the skin, the cream also has properties of cucumber in it that leads to reduced pigmentation and blemish free skin. With consistent use, the eye area becomes more brilliant and clear thanks to anise and chakshushya.

The Shiseido Ultimune Power Infusing Eye Concentrate combats signs of ageing and drooping skin and defends your delicate under eyes against damage in one application. If you're guilty of scrubbing your eyes till you see all black like me this serum is made for you. It heals your skin against the harsh friction and other environmental factors and is the perfect pre-treatment before your eye serums to give that extra boost to your daily skincare.

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6 Under Eye Products You Need To Have STAT - Grazia India

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OverviewWhat is bone marrow?

Bone marrow is the soft, fatty tissue inside of bone cavities. Components of your blood including red and white blood cells and platelets form inside of your bone marrow.

Bone marrow makes nearly all the components of your blood. It's responsible for creating billions of red blood cells daily, along with white blood cells and platelets. Bone marrow also stores fat that turns into energy as needed.

Bone marrow makes the components of your blood that you need to survive. Bone marrow produces red blood cells that carry oxygen, white blood cells that prevent infection and platelets that control bleeding. The absence of bone marrow can be fatal since it's an essential part of your body.

Yes, bone marrow and the healthy cells it produces are necessary for humans to live. Often, cell mutations harm healthy bone marrow cells, and a bone marrow transplant would be a treatment option for people diagnosed with blood cancers like leukemia.

A bone marrow transplant takes healthy cells from a donor and puts them into your bloodstream. The donors cells help your body grow healthy red and white blood cells and platelets.

There are three parts to the anatomy of your bones: compact bone, spongy bone and bone marrow. Compact bone is the strong, outer layer of your bones. Spongy bone makes up the ends of your bones. Bone marrow is in the center of most bones and in the end of spongy bones in your body. Bone marrow and blood vessels fill cavities in your bones, where they store fat and stem cells and produce blood cells that make your whole blood.

Bone marrow is a spongy, soft tissue that resembles a jelly or jam that you would spread on toast. It comes in two colors, red and yellow. Bone marrow fills the cavities of your bones and holds cells that create red and white blood cells and platelets, which make whole blood. The color of red bone marrow is the result of red blood cell production.

There are two types of bone marrow in your body, which are characterized by their color. Your body holds just under 6 lbs. (about 2.5 kg.) of red and yellow bone marrow.

Red bone marrow makes up all of your bone marrow until about age seven. Yellow bone marrow gradually replaces red bone marrow as you age.

Bone marrow is made of stem cells. These stem cells make red bone marrow, which creates blood cells and platelets for your blood. Yellow bone marrow consists mostly of fat and stem cells that produce bone and cartilage in your body.

Directly targeting bone marrow is leukemia, which is a blood and bone marrow cancer. Leukemia forms when a cell mutation occurs in your bone marrow and mutated cells multiply out of control, reducing the production of healthy, normal cells.

Since bone marrow is the foundation for the creation of blood cells, blood-related conditions often are the result of abnormally functioning bone marrow. These conditions include:

Common symptoms of bone marrow conditions include:

There are two tests to check the health of your bone marrow and/or blood cells:

For a bone marrow test or donation, youll receive an anesthetic, so you won't feel any pain during the procedure. After the procedure, you may feel side effects, which include aches and pain at the site of the incision. Each individual experiences pain differently, so the severity could vary from person to person. The pain may last for a few days or up to several weeks.

Treatments for bone marrow conditions vary based on the severity and progress of the diagnosis. Treatment options include:

Bone marrow is the foundation of your bones, blood and muscles. Keeping your bone marrow healthy focuses on supporting components of your body that grow from bone marrow cells. You can keep your bone marrow healthy by:

A note from Cleveland Clinic

Bone marrow is the soft center of the bones in your body. Bone marrow is necessary to create components of your blood and store fat. The best way to keep your bone marrow healthy is to support the parts of your body that your bone marrow produces, like your blood, muscles and bones.

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Bone Marrow: What it is & Why it is Important - Cleveland Clinic

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We explain a protocol for straightforward isolation and culture of mesenchymal stem cells (MSCs) from mouse bone marrow (BM) to supply researchers with a method that can be applied in cell biology and tissue engineering with minimal requirements. Our protocol is mainly on the basis of the frequent medium change in primary culture and diminishing the trypsinization time. Mouse mesenchymal stem cells are generally isolated from an aspirate of BM harvested from the tibia and femoral marrow compartments, then cultured in a medium with Dulbecco's modified Eagle's medium (DMEM) and fetal bovine serum (FBS) for 3 h in a 37 degrees C-5% CO(2) incubator. Nonadherent cells are removed carefully after 3 h and fresh medium is replaced. When primary cultures become almost confluent, the culture is treated with 0.5 ml of 0.25% trypsin containing 0.02% ethylenediaminetetraacetic acid for 2 min at room temperature (25 degrees C). A purified population of MSCs can be obtained 3 weeks after the initiation of culture.

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A protocol for isolation and culture of mesenchymal stem cells from ...

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As cancer treatments continue to advance and new therapies are introduced, it's easy to get lost in your search for information. To help you better understand the differences between specific cancer treatments and how they work, we spoke with medical oncologist Bhavina Sharma, MD, MPH.

"Chemotherapy are drugs designed to directly attack all rapidly dividing cells in the body, including cancer cells," explains Dr. Sharma. "It relies on the idea that cancer cells reproduce much faster than most healthy cells in our body."

Chemotherapy drugs can be given by infusion or in pill form. Unfortunately, these drugs can't tell the difference between cancerous cells and fast-growing healthy cells like the gastrointestinal tract and hair follicles, leading to side effects such as diarrhea and hair loss. Thankfully, recent advancements in chemotherapy have helped lessen side effects such as nausea, pain and lethargy.

Targeted therapy are special drugs designed to target differences within cancer cells that help them thrive. Unlike chemotherapy, targeted therapy drugs actually change the inner workings of the cancer cell. Because targeted therapy focuses on the part of the cancer cell that makes it different from the normal, healthy cell, it often has fewer side effects than standard chemotherapy treatments.

Immunotherapy is very different than chemotherapy in that it helps our immune system to find and kill cancer cells.

"Cancer cells are abnormal cells that have formed in our body because of cell damage or mutations," explains Dr. Sharma. "Cancer cells hide from your immune system by shutting down certain pathways of the immune response. Immunotherapy unlocks those pathways so your immune system can recognize and remove the cancer cells."

Cellular therapies are treatments that improve the body's ability to fight cancer. "Stem cell therapy falls under the umbrella of cellular therapy," explains Dr. Sharma. "It uses stem cells to mount an immune response to attack your cancer cells."

Stem cells from blood and bone marrow can be used in transplants. These stem cells can either come from a matched donor (allogeneic) or from the patient themselves (autologous).

Chimeric antigen receptor therapy or CAR T-cell, is a type of cellular therapy.

"T cells are white blood cells that help our bodies fight infection and cancer," explains Dr. Sharma. "With CAR T-cell therapy, your own T cells are collected from your blood. These T cells are modified to recognize cancer as a foreign cell and attack it."

CAR T-cell therapy has been approved by the Food and Drug Administration to treat lymphoma, leukemia and multiple myeloma.

Hormone therapy slows or stops the growth of cancer that uses hormones to grow. It is also called hormonal therapy, hormone treatment or endocrine therapy. Hormone therapy is recommended for cancers that are hormone-receptor positive, such as certain breast and prostate cancers. It can't be used in cancers that don't carry hormone receptors.

"Hormone therapy can be used for both early stage and metastatic hormone-receptor positive breast cancers," explains Dr. Sharma. "In patients with early-stage breast cancer, it is used after surgery to help reduce the risk of the cancer coming back."

Chemotherapy, immunotherapy, targeted therapy, and hormone therapy are just a few of the treatments we use to treat cancer. Many of these cancer treatments can be combined with others like cancer surgery and radiation therapy. Every person's journey through cancer is different. Your oncology team will help you sort through the best therapies available to create your treatment plan.

The information in this article is for information purposes only. For specific questions regarding your medical condition or treatment plan, please consult with your doctor directly. To schedule an appointment with a Nebraska Medicine cancer specialist, call 402.559.5600.

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Are immunotherapy and chemotherapy the same thing? How cancer treatments work - Nebraska Medicine

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BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced the presentation of new long term follow-up data and health-related quality of life scores of patients treated with omidubicel at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO), being held in Houston, Texas.

These data reinforce our commitment to advance transformational cell therapy research and underscore the potential of our NAM technology platform. Our lead stem cell therapy candidate, omidubicel, addresses the unmet need for patients with hematologic malignancies, demonstrated by the robust and growing body of encouraging clinical evidence, including the long-term follow up data and quality of life improvement, said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. As we approach the PDUFA date of January 30, 2023, and upon potential FDA approval, we are prepared to execute our plan that ensures access to those patients who can benefit from omidubicel as quickly as possible.

The long-term, durable clinical benefit of omidubicel was observed at three years across a patient population that typically has a poor prognosis. A study titled, Multicenter Long-Term Follow Up of Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials, highlighted long-term follow-up of 105 patients transplanted with omidubicel between 2006-2020 (median follow-up of 22 months). The data demonstrated an overall survival and disease-free survival of 63% (95% CI, 53%-73%) and 56% (95% CI, 47%-67%) at three years, respectively, as well as durable long-term hematopoiesis and immune competence. Learn More

Overall well-being health-related quality of life scores for patients treated with omidubicel demonstrated clinical benefit compared to standard of care. A study titled, Health-Related Quality of Life Following Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel Versus Standard Umbilical Cord Blood featured an analysis of 108 patients that completed validated health-related quality of life (HRQL) surveys on screening and days 42, 100, 180, and 365 post-transplant. Measures of physical and functional well-being and other HRQL scores were more favorable with omidubicel. These data suggest clinically meaningful and sustained improvements in physical, functional, and overall well-being compared to umbilical cord blood transplantation. Learn More

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types including stem cells and natural killer cells with appropriate growth factors to maintain the cells active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.

About Gamida Cell

Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapy candidates with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of, and data reported from, the clinical trials of Gamida Cells product candidates (including omidubicel), regulatory filings submitted to the FDA (including the potential timing of the FDAs review of the BLA for omidubicel), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cells product candidates (including omidubicel), and Gamida Cells expectations for the expected clinical development milestones set forth herein. Any statement describing Gamida Cells goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on May 12, 2022, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cells forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.

1CIBMTR 2019 allogeneic transplants in patients 12+ years with hematological malignancies.2Gamida Cell market research

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Long-Term Data from Omidubicel Phase 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers at the...

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Dr. Jeff Hersh| Daily News Correspondent

Q: What is CAR T-cell therapy?

A: Our immune system protects our bodies from "invasion"by harmful substances, infections and abnormal cells (for example cancer cells). T-cells (also called T-lymphocytes or thymocytes) develop from stem cells in the bone marrow and mature in the thymus (a body organ in the neck that is part of the lymphoid system, along with the spleen, lymph nodes and the red bone marrow).

Cytotoxic T-cells identify body cells that have certain antigens (proteins on the surface of certain cancer cells, cells that have become infected, other cells) and directly kill them.

Helper T-cells detect various "invasions"and release cytokines to activate other immune system cells (including cytotoxic T-cells) to combat them.

Regulatory T-cells help moderate the immune response to maintain balance and the bodys ability to tolerate (rather than attack) itself (for example helping minimize inappropriate inflammatory responses).

This description of T-cells shows why it would be helpful to "manipulate"them in a specific manner to leverage the immune system to help fight certain diseases/conditions. This is where chimeric antigen receptor (CAR) T-cells come into play.

White blood cells (including T-cells) are collected from the patient by taking some of their blood via an intravenous (IV) catheter and filtering out the white cells using a leukapheresis machine, and then putting the filtered blood (minus the extracted white blood cells) back into the patient via a second IV catheter.

The T-cells are then separated from the other white blood cells, and a gene for the "targeted" antigen is added to the cells (you can think of this as a "lock and key"mechanism, with the antigen being the "lock"and the protein added to the T-cell being the "key"used to identify the "invading" cell with that particular antigen "lock."

These modified cells (the CAR T-cells) are then "multiplied"in the lab to create a large number of them. The CAR T-cells are then infused into the patient (again via an IV). These CAR T-cells can now specifically "hunt"the specific "invading"cell(s) they have been created to target.

There are many steps needed to create this personalized CAR T-cell treatment for an individual patient, and therefore it can take weeks to produce these treatments. In the future it may be possible to pre-prepare treatments from donor T-cells (possibly modifying these cells to target specific antigens using techniques like CRISPR, mRNA techniques, etc.) and then transfuse the appropriate CAR T-cells in a manner similar to how other blood products (for example red cells, platelets, etc.) are transfused to help a patient.

Since 2017 CAR T-cells have been specifically designed and utilized to treat individual patients with several different types of "blood cancers"(lymphomas, leukemias and multiple myelomas) that did not respond to the standard treatments (for example chemotherapy for that type of cancer).In many patients with very difficult to treat blood cancers, these treatments have been very effective.

Solid tumors (as opposed to blood cancers), such as brain, breast, lung and pancreatic cancers, are a bit more challenging to address with the CAR T-cell approach.This is because having the CAR T-cells gain "access"to the solid tumor cancer cells is more difficult.

From the description of T-cells above, it seems that this same conceptual approach might be utilized to treat certain autoimmune conditions (conditions where a patients own immune system "overreacts"and attacks the patients own body cells), and this has recently been studied. In this study, five patients with severe lupus who had not responded to standard treatments were treated with specifically designed CAR T-cells to "wipe out"the aberrant B cells causing their autoimmune complications, and all five showed very significant improvement. Future clinical studies will no doubt be designed to see what other conditions might benefit from this treatment approach!

However, treatment with CAR T-cells is not without risk, as these treatments can sometimes cause serious and even life-threatening complications. For example, some patients have had:

Cytokine release syndrome (CRS), where the patient reacts to the CAR T-cell infusion with an aggressive release of cytokines that causes an inflammatory reaction (for example causing symptoms like fever, breathing issues, gastrointestinal issues, other symptoms); nervous system issues (for example headaches, seizures, alterations in consciousness, others), and there may bemany other possible complications.

Bottom line: CAR T-cell therapy has become a more and more accepted therapeutic approach, and in the future it may be utilized earlier in a patients disease (rather than only for refractory cases), and for a broader array of disease states (not just blood cancers, but potentially autoimmune conditions, maybe certain solid tumors, and potentially other diseases).

Jeff Hersh, Ph.D., M.D., can be reached at DrHersh@juno.com.

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CAR T-cell therapy is new approach to fighting cancer, other diseases - MetroWest Daily News

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Diagnosis, Treatment, and Prevention of Blood Cancer By Dr Gaurav Kharya

Written by Tavishi Dogra | Updated : October 4, 2022 9:56 PM IST

In India, the increase in cancer cases over the past ten years has become a significant public health problem for the country. These cases have a long latent period, are primarily lifestyle-related and require specialised infrastructure and human resources to be treated. Cancer's physical, psychological and financial toll on people, families, communities and health systems keeps rising. The prevalence of cancer varies across India's regions, making prevention and management extremely difficult. Due to cancer not being a notifiable disease, the national burden assessment is still a task for which many developing nations, including India, rely on statistical models. The estimated number of cancer-related Disability-adjusted life years (DALYs) (AMI) in India in 2021 was 26.7 million, and that number was predicted to rise to 29.8 million in 2025.

Each year, 1.24 million new instances of blood cancer are reported worldwide, making up about 6% of all cancer cases. Blood cancer develops in the bone marrow, tissues that create blood and compromise the immune system. According to incidence rates, there are primarily three different forms of blood cancers: lymphoma/leukaemia, multiple myeloma, myelodysplastic syndromes (MDS)/myeloproliferative neoplasms (MPN). In addition, blood cancer may arise when the body produces abnormal White Blood Cells (WBCs). It typically starts in the bone marrow, which produces blood in our body. This malignancy impairs the normal development, growth and functioning of blood cells that fight infection and produce healthy blood cells.

White blood cells produced by the body during leukaemia are incapable of battling infections. Depending on the type of blood cell involved and whether it is fast-growing or slow-growing (acute or chronic), leukaemia is divided into distinct forms (myeloid or lymphoid). Consequently, it can be broadly divided into four subtypes: acute lymphocytic leukaemia (ALL), acute myeloid leukaemia (AML), chronic lymphocytic leukaemia (CLL) and chronic myeloid leukaemia (CML). Apart from these are some rare blood cancers such as Juvenile myelomonocytic leukaemia (JMML).

Diagnosis, Treatment, and Prevention of Blood Cancer By Dr Gaurav Kharya, Clinical Lead Apollo Center & Indraprastha Apollo Hospital

Various diagnostic techniques are used to identify blood cancer, including clinical examination, blood testing, bone marrow tests, cytogenetic/karyotyping, molecular analyses, and flow cytometry. Most pediatric patients diagnosed with ALL or AML can be treated by chemotherapy. However, a smaller percentage of patients who don't respond well to chemotherapy are candidates for Bone marrow transplant to offer a long-term cure to these patients. In contrast, almost half of adult patients need BMT as consolidation to provide long-term treatment. If required, BMT can safely be done now using half HLA identical donors in case HLA matching donors are unavailable in experienced centres.

In most cases, the doctor will make a treatment recommendation based on research on the most effective treatments and national recommendations developed by experts. They will assess the type of blood cancer, the outcomes of any tests the patient has had, the state of the overall health, the available therapies, their effectiveness, and any potential risks or side effects.

There is a range of different treatments for blood cancer. But the most common ones include:

The cost of blood cancer therapy in India has several significant advantages. First, the most outstanding hospitals in India, equipped with the most cutting-edge equipment and a staff of oncologists and doctors with years of experience, are accessible to offer blood cancer patients comprehensive care.

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Prevalence Of Blood Cancer In India: Know Its Prevention And Management | TheHealthSite.com - TheHealthSite

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NEW YORK, Oct. 4, 2022 /PRNewswire/ --

Growing Use of IVF and Stem Cell Therapies to Create US$ 323 Million Market Opportunity for Carbon Dioxide Incubator Manufacturers

The carbon dioxide incubators market is well covered by Fact.MR for the upcoming decade. The study looks closely at key growth factors such trends, future projections, and business strategies. The research also provides a thorough analysis of the top segments including product, application, capacity, and region, in order to provide well-rounded perspective.

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Fact.MR A Market Research and Competitive Intelligence Provider: The global carbon dioxide incubators market is likely to reach US$ 483.5 Million by 2027, growing at 8.4% CAGR between 2022 and 2027. Growing investment in research and clinical trial activities is likely to fuel the sales of carbon dioxide incubators during the assessment period. Further, use of carbon dioxide incubators in IVF and stem cell treatments is also likely to drive growth.

The popularity and acceptance of in-vitro fertilizations has grown significantly. According toNational Library of Medicine, around 10% to 15% couples in the U.S. have trouble in having a baby. These challenges have been well-addressed by in vitro fertilization (IVF), owing to which it has become a popular healthcare solution.

Use of in-vitro fertilization (IVF) to help couples in becoming parents is likely to grow in the future, which is likely to drive demand for accessories and equipment used in this process. Owing to this, demand for carbon dioxide incubators is likely to witness an upward trend over the upcoming decade.

Further, sales of carbon dioxide incubators are also likely to increase on account of growth in overall stem cell procedures. For instance, as perHealth Resources and Services Administration, 4,864 unrelated and 4,160 related bone marrow and cold transplants were conducted in the U.S. in 2020. Growing use of stem cell treatment is likely to be a key factor driving the sales of carbon dioxide incubators during the assessment period.

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Globally, North America and Europe are likely to remain at the pinnacle of growth in the carbon dioxide incubators market. The U.S., U.K., France, and Germany are at the forefront of new innovation in R&D, and sales of medical accessories and equipment will also remain high, as per Fact.MR. Owing to these factors, carbon dioxide incubator manufacturers are likely to witness incremental growth opportunities across these regions.

Key Takeaways:

By product, water-jacketed carbon dioxide incubators are likely to reman preferred among end-users.

By capacity, below 100-liter carbon dioxide incubators are expected to witness high demand during the assessment period.

By application, use of carbon dioxide incubators in laboratory research and clinical applications is likely to remain high during the assessment period.

By region, North America and Europe are likely to hold sway over the forecast period, with the U.S. and the U.K. leading the growth.

China and India are expected to create sizeable opportunities for market players on the back of improved healthcare infrastructure.

Growth Drivers:

Increasing applications of carbon dioxide incubators in in-vitro fertilization (IVF) and stem cell treatment is likely to drive the market.

Use of carbon dioxide incubators in cell culture development and tissue engineering is expected to create growth avenues for market players.

Efficiency of incubators in maintaining consistent temperature during genetically modified organism (GMO) cultivation is expected to drive growth.

Advancement in carbon dioxide incubator technology is likely to create new growth avenues for market players.

Restraints:

Carbon dioxide incubators are highly prone to errors due to which they require highly experienced technicians. Due to skill shortage, sales of these incubators can be limited.

Lack of standardization is a longstanding challenge and failure to address this issue might hamper growth.

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Competitive Landscape:

Carbon dioxide incubator manufacturers are focusing on launching innovative technologies to consolidate their position in the market. Further, leading players are concentrating on providing training and guidelines to end-users so their products can be used without any issue.

For instance,

In May 2021, Esco introduced an innovative incubator featuring High Heat Sterilization that is highly effective in eliminating bacteria and vegetative cells.

In January 2020, CO2Meter Inc., launched incubators that regulate and monitor bacterial development patterns.

Key Companies Profiled by Fact.MR

More Valuable Insights on Carbon Dioxide Incubators Market

In its latest study, Fact.MR offers a detailed analysis of the global carbon dioxide incubators market for the forecast period of 2022 to 2027. This study also divulges key drivers and trends promoting the sales of carbon dioxide incubators through detailed segmentation as follows:

By Product:

Water Jacketed

Air Jacketed

Direct Heat

By Capacity:

Below 100 Litres

100-200 Litres

Above 200 Litres

By Application:

By Region:

North America

Latin America

Europe

East Asia

South Asia & Oceania

MEA

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Key Questions Covered in the Carbon Dioxide Incubators Market Report

What is the estimated market size of carbon dioxide incubators in 2022?

At what pace will worldwide carbon dioxide incubators sales increase till 2027?

What factors are driving demand in the carbon dioxide incubators market?

Which region is predicted to lead the worldwide carbon dioxide incubators market between 2022 and 2027?

What are the elements driving carbon dioxide incubators market sales during the forecast period?

What is the expected market estimation of the carbon dioxide incubators market during the forecast period?

Explore Fact.MR's Coverage on the Healthcare Domain

Biological Indicator Incubator Market:The biological indicator incubators market is projected to benefit from rising biopharmaceutical production. The market for biological indicator incubators may continue to increase quickly as a result of the manufacturing of biopharmaceuticals that are grown via cell culture.

Tissue Culture Incubator Market:The introduction of CO2 incubators with infrared radiation control systems and other technological advancements in tissue culture incubators, along with increased funding for tissue-based research, are anticipated to be major factors driving the growth of the tissue culture incubator market over the forecast period.

Pneumatic Nebulizers Market:Pneumatic nebulizer sales are anticipated to grow steadily at a CAGR of 4% and reach a market value of US$ 850.4 million by 2027 from US$ 699 million in 2022. An increase in local healthcare spending and patient awareness has spurred the need for pneumatic nebulizers.

Implantable Medical Devices Market: The global implantable medical devices market is predicted to reach US$ 155 billion by 2027. Key factors driving market growth include rising geriatric population & burden of chronic diseases and increasing demand for cosmetic dentistry.

Disinfection Caps Market: Key factors driving market growth include stringent regulations for safe injection practices and rising prevalence of hospital-acquired infections across the world. The global disinfection caps market is estimated to reach US$ 420 million by 2027.

Check it Out More Reports by Fact.MR on Healthcare Domain

https://www.factmr.com/industry/healthcare

About Fact.MR

Fact.MR is a market research and consulting agency with deep expertise in emerging market intelligence. Spanning a wide range from automotive & industry 4.0 to healthcare, technology, chemical and materials, to even the most niche categories. We are committed to deliver insights that help businesses gain deeper understanding of their target markets. We understand that making sense of the vast labyrinth of data can be overwhelming for businesses. That's why focus on offering insights that can actually make a difference to bottom-lines.

Specialties:Competition Tracking, Customized Research, Syndicated Research, Investment Research, Social Media Research, Business Intelligence, Industry Analysis, Thought Leadership.

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Carbon Dioxide Incubators Market to Reach US$ 483.5 Million by 2027 as Application in In Vitro Fertilization Rises - Yahoo Finance

Bone Marrow Stem Cells Comments Off on Carbon Dioxide Incubators Market to Reach US$ 483.5 Million by 2027 as Application in In Vitro Fertilization Rises – Yahoo Finance | October 5th, 2022

Pain.

It gnawsat you. It drains you. It becomes the focus of your life.

Experiencing a few pain-free moments can be euphoric; it makes you realize how long youve been living with aches and pain. You might wonder how you can find a solution to relieve the pain and regain your freedom from discomfort.

Regenerative Spine and Pain Institute on how to lesson your pain.

Dr. Ronak Patel at Regenerative Spine and Pain Institute wants you to know there are two new revolutionary answers to pain relief.

Both platelet-rich therapy otherwise known as PRP and stem cell therapy give patients new hope by using the bodys powerful healing power to accelerate the battle against pain. Dr. Patel has seen incredible success implementing these cutting-edge treatments on hundreds of patients suffering from pain-related issues.

So if you are suffering fromany of the ailments below, theres a lifeline.

Heres the best news: Neither PRP or stem cell therapy involves drug use with side effects or any surgical procedures.

Both PRP and stem cell treatments use the bodys own healing resources to repair diseased or damaged tissue and the results are quite remarkable.

PRP therapy involves injecting concentrated platelets and growth factors into damaged tissue to stimulate the faster growth of new healthy cells. Platelets are cells that prevent and stop bleeding. If a blood vessel is damaged, the body sends signals to our platelets to get on the job and start the healing. Some call platelets the bodys natural bandage.

So how does PRP therapy work? Its basically drawing a one small vial of blood from the patient and then using a centrifuge to turn it into a potent and concentrated form of platelets. It is then injected back into the patient. Think of it as a boost of your own blood only superpowered.

Recovery time for PRP therapy is far shorter than for surgery. Patients usually experience soreness for a week or so, but the gradual improvement soon begins. Unlike a steroid shot, which gives you immediate relief and quickly wears off, a PRP patient will see pain symptoms improve over a period of months, and up to 80 percent of patients will see relief for up to two years.

Stem cell therapy can be an even more powerful way to harness the bodys healing power. Stem cells are the building blocks for every cell in our body. These powerful cells can be harvested to produce powerful new cells to fight inflammation and disease.

For those suffering from osteoarthritis, stem cell therapy has proven very effective. Thats because the stem cells may help develop new cartilage cells and suppress inflammation. Stem cells can be harvested through a sample of body fat or bone marrow or be harvested from donated umbilical cord tissue.

And yes, you can even augment PRP therapy with stem cell therapy for an even bigger boost!

Stop wondering if youll have to live with your pain forever. Contact Regenerative Spine and Pain Institute today at 609-269-4451 or go to http://www.njpaindoc.com to book an appointment and learn more.

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Regenerative Spine and Pain Institute: Treating Pain with PRP and Stem Cell Therapy - Community News

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AMSBIO has published an interview with Professor Marius Wernig from Stanford University, Pathology Stem Cell Institute that discusses what could be the worlds first widely applicable curative treatment for Epidermolysis Bullosa (EB).

This rare genetic disease causes chronic and incredibly painful skin wounds that often lead to an aggressive form of skin cancer and eventual death.

While various cell-therapy approaches have been attempted, Professor Wernig and collaborators identified the need for induced pluripotent stem cells (iPSCs), and how they could become used to treat EB in a more efficient, applicable, and commercially viable manner.

In the past, the only way Professor Wernigs research group could grow iPSCs cells with a normal karyotype over longer periods of time was on mouse feeder cells with serum. This combination of mouse cell co-culture and undefined bovine serum set was not a suitable methodology as it was almost impossible to perform in compliance with FDA safety standards.

Professor Wernig describes how StemFit Basic03 clinical grade stem cell culture medium, available from AMSBIO has allowed his research group to safely expand their cells using an FDA compliant protocol. While there are still hurdles to climb before a cure for EB is fully realised, using StemFit Basic03 has solved the challenge of reproducibly growing clinical grade iPSCs.

Read the full interview.

Completely free of animal- and human-derived components StemFit Basic03 provides highly stable and reproducible culture condition for Induced Pluripotent Stem and Embryonic Stem cells under feeder-free conditions during the reprogramming, expansion, and differentiation phases of stem cell culture. StemFit Basic03 combines high colony forming efficiency with lower than standard media volume consumption to offer cost effective colony expansion when compared to leading competitors.

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iPS-Cell Based Cell Therapies for Genetic Skin Disease

IPS Cell Therapy Comments Off on iPS-Cell Based Cell Therapies for Genetic Skin Disease | October 5th, 2022

JCR Pharmaceuticals Co., Ltd. and Sysmex Corporation announced that they have established a joint venture(hereafter the "joint venture") for carrying out research and development, manufacture and sales of cell-based regenerative medicine products including hematopoietic stem cells and other stem cells. In recent years, the significant potential of regenerative medicine and cell therapy have been established in particular in areas that have traditionally been difficult to address with conventional chemically synthesized low molecular weight drugs1 or biopharmaceuticals2, such as the restoration of tissues and functions lost as a result of aging, illness, autoimmune diseases, or cancer. In particular, research and development on the therapeutic application of stem cells including hematopoietic stem cells, mesenchymal stem cells, and iPS cells have generated significant attention. Since its inception, JCR has been engaged in the research, development, manufacturing and sales of pharmaceutical products using regenerative medicine, genetic engineering, and gene therapy technologies to advance therapies in the rare disease field. This is exemplified in the field of regenerative medicine, by the approval of TEMCELL HS Inj.3, the first allogeneic regenerativemedicine in Japan (Non-proprietary name: Human (allogeneic) bone marrow-derived mesenchymal stem cells) in February 2016 for the treatment of acute graft-versus-host disease (acute GVHD)4, a serious complication that develops after hematopoietic stem cell transplantation. In recent years, JCR has further streamlined and integrated its expertise around the establishment of groundbreaking medicines for the advancement of highly innovative medicines that could not be developed without such groundbreaking technologies. In the joint venture, the two companies aim to realize the social implementation of regenerative medicine and cell therapy by integrating JCR's expertise in developing, manufacturing and marketing regenerative medicine products, with Sysmex's expertise in quality control testing technology and knowledge of workflows efficiency using robotics technology, including IoT. AlliedCel Corporation, which is the corporate name of the joint venture following prior discussions regarding the alliance both companies, was established on October 3, 2022. The joint venture will advance programs of the potential for technology development and commercialization, including the project currently being promoted by both companies using hematopoietic stem cell proliferation technology. The name AlliedCel stands for the joint venture's aspiration to integrate knowledge and expertise from a broad set of collaborators and stakeholders including business partners, patients and their families, with the united goal of unleashing the power of cells in supporting patients in their needfor life-changing therapies. Through the research and development of regenerative medicineproducts using diverse cells such as stem cells, AlliedCel aims to provide appropriate treatmentoptions to patients and improve their prognosis.

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Jcr Pharmaceuticals Co., Ltd. and Sysmex Establish A Joint Venture in the Field of Regenerative Medicine and Cell Therapy - Marketscreener.com

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MeiraGTx

Multiple Poster Presentations Highlight Versatility and Novelty of MeiraGTxs Technology Platforms for Gene and Cell Therapy

LONDONandNEW YORK, Oct. 04, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc(Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company will exhibit 15 poster presentations at the European Society of Gene and Cell Therapy (ESGCT) 2022 Annual Congress, which will be held from October 11-14, 2022, in Edinburgh, Scotland.

The posters will include data from MeiraGTxs novel gene regulation platform, including the first data demonstrating the potential to regulate CAR-T, as well as data from the Companys promoter platforms and several new, optimized pre-clinical programs addressing severe unmet needs for indications such as amyotrophic lateral sclerosis (ALS) and Wilsons disease. In addition, the Company will have presentations on its proprietary viral vector manufacturing technology and potency assay development.

Were pleased to present data illustrating the depth and versatility of MeiraGTxs scientific platforms, said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. The 15 published abstracts at this years ESGCT Congress reflect the extraordinary productivity of our research efforts in developing new technologies and applying them to the design of optimized genetic medicines, as well as innovation in manufacturing and process development technology. I am particularly excited for us to present our riboswitch gene regulation technology applied to cell therapy for the first time, in this case the regulation of CAR-Ts, which is a huge area of scientific and clinical interest, continued Dr. Forbes. We look forward to presenting these data highlighting our innovative platform technologies and broad R&D capabilities.

Abstract Title (P101): AI-driven promoter optimization at MeiraGTxSession Title: Advances in viral and non-viral vector designDate: October 12, 2022

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Abstract Title (P124): Promoter Engineering Platform at MeiraGTxSession Title: Advances in viral and non-viral vector designDate: October 13, 2022

Abstract Title (P243): UPF1 delivered by novel expression-enhanced promoters protects cultured neurons in a genetic ALS modelSession Title: CNS and sensoryDate: October 12, 2022

Abstract Title (P254): Optimization and scale-up of AAV2-AQP1 production using a novel transient transfection agentSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P264): Designing and screening formulations to improve manufacturability and distribution of AAV gene therapiesSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P270): Use of anion exchange chromatography to provide high empty AAV capsid removal and product yieldsSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P320): Multivariate analysis for increased understanding of MeiraGTx upstream processSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P362): Development of AAV-UPF1 gene therapy to rescue ALS pathophysiology using microfluidic platformsSession Title: Disease models (iPS derived and organoids)Date: October 13, 2022

Abstract Title (P399): Titratable and reversible control of CAR-T cell receptor and activity by riboswitch via oral small moleculeSession Title: Engineered T and NK CARs and beyondDate: October 12, 2022

Abstract Title (P436): Novel riboswitches regulate AAV-delivered transgene expression in mammals via oral small molecule inducersSession Title: Gene and epigenetic editingDate: October 13, 2022

Abstract Title (P553): Development of optimized ATP7B gene therapy vectors for the treatment of Wilsons Disease with increased potencySession Title: Metabolic diseasesDate: October 12, 2022

Abstract Title (P554): A CNS-targeted gene therapy for the treatment of obesitySession Title: Metabolic diseasesDate: October 13, 2022

Abstract Title (561): Riboswitch-controlled delivery of therapeutic hormones for gene therapySession Title: Metabolic diseasesDate: October 12, 2022

Abstract Title (P622): Riboswitch-controlled delivery of therapeutic antibodies for gene therapySession Title: OtherDate: October 13, 2022

Abstract Title (P630): Improving AAV in vitro transducibility for cell-based potency assay developmentSession Title: OtherDate: October 13, 2022

About MeiraGTxMeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, and a transformative gene regulation platform technology which allows tight, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring, and developing technologies that give depth across both product candidates and indications. MeiraGTxs initial focus is on three distinct areas of unmet medical need: ocular, including inherited retinal diseases and large degenerative ocular diseases, neurodegenerative diseases, and severe forms of xerostomia. Though initially focusing on the eye, central nervous system, and salivary gland, MeiraGTx plans to expand its focus to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

For more information, please visit http://www.meiragtx.com.

Forward Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and our pre-clinical data and reporting of such data and the timing of results of data, including in light of the COVID-19 pandemic, as well as statements that include the words expect, will, intend, plan, believe, project, forecast, estimate, may, could, should, would, continue, anticipate and similar statements of a future or forward-looking nature. These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SECs website at http://www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts

Investors:MeiraGTxInvestors@meiragtx.com

Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com

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MeiraGTx Announces the Upcoming Presentation of 15 Abstracts at the European Society of Gene and Cell Therapy (ESGCT) 2022 Annual Congress - Yahoo...

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The future possibilities of regenerative Medicine are endless. Know how regenerative medicine for heart diseases is better than conventional treatments.

Written by Longjam Dineshwori | Updated : October 5, 2022 9:52 AM IST

In the past few days, news of people dying due to cardiac arrest and heart attack during the festivities have been making headlines. Concerningly, increasing number of younger people, precisely adults who are in their 30s, are getting heart problems today. Health experts have been advising people to maintain a healthy lifestyle to prevent heart diseases or at least delay their onset. Also, tremendous advancements have been made in the field of cardiology making treatment of heart ailments more effective and less invasive. One of them is regenerative medicine, which is now being explored for the treatment of several diseases.

Get to more about regenerative medicine and its possibilities for treating heart diseases from Dr Pradeep Mahajan, Regenerative Medicine Researcher, Stem Rx Bioscience Solutions Pvt. Ltd, Navi Mumbai.

An alarming one out of four deaths in our country today is due to heart disease. This is largely due to our sedentary lifestyles, unhealthy eating habits, and stress. Barring the heart conditions that are present from birth (congenital) or that are passed down through the generations (inherited), heart diseases can be prevented or at least the onset can be delayed by maintaining a healthy lifestyle.

The field of cardiology (relating to the heart) has advanced tremendously, and there are several medications and surgical procedures that help patients maintain the functions of the heart. However, these call for invasive treatments and the need for life-long medications. Moreover, the side effects of medicines should also be taken into account.

Enter the field of Regenerative Cardiology! As the word suggests, this branch refers to utilising the natural healing potential of the body to repair and re-grow damaged heart tissues. Stem cells have been researched in several heart diseases to overcome the damage to the heart and facilitate healing. Not just stem cells, but cell-based products like exosomes, molecular chaperones, growth factors etc. have shown promise as well. Do not think about the technicalities, all these molecules are present in our body and researchers and clinicians are now working on how to apply these for the treatment of several diseases.

Commonly, we hear of blocks in the heart, infection, and weak muscles of the heart that do not pump blood properly leading to various diseases. With cell-based therapies, we can tackle each of these issues. Stem cells (the most basic 'unspecialized' cells of our body) can multiply and form various cells of the body, including heart cells. Similarly, cell products like exosomes are cargo packets they carry the required substances for repair and re-growth of tissues. These biological molecules have 'housekeeping functions, meaning that they ensure that any unwanted product and even bacteria/viruses are removed periodically from the body.

The possibilities of Regenerative Medicine for heart diseases are many blocks in the heart can be dissolved, blood supply can be improved, heart muscles can be strengthened, etc. because these biological molecules are capable of reducing inflammation (swelling) in the body, modify the immune system to function better, enhance the functions of other cells, etc. Since these are part of our own body, providing these molecules in the appropriate quantity at the desired site will enhance healing without side effects. In fact, there is ongoing research on growing healthy heart tissue in labs with these biological molecules to transplant them into the human body. Who knows, someday the whole heart might be grown in a lab! While the future possibilities are endless, the current cell-based therapies can be a definitive addition to enhance the outcomes of existing conventional treatments. Of course, rehabilitation and lifestyle modifications are mandatory to maintain the results.

A holistic approach is important one cannot simply rely on symptom management the core issues have to be targeted and Regenerative Medicine can do just that. The death rate due to heart disease can be reduced and patients will be able to have a better quality of life.

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EAST LANSING, Mich. A chemical released during sex could become a new treatment for heart attack patients, new research reveals. Oxytocin, called the love hormone, helps heal the organ by boosting production of stem cells, researchers at Michigan State University say.

The findings are based on human tissue grown in the lab and experiments on zebrafish, which have a remarkable ability to repair themselves.

Here we show that oxytocin, a neuropeptide also known as the love hormone, is capable of activating heart repair mechanisms in injured hearts in zebrafish and human cell cultures, opening the door to potential new therapies for heart regeneration in humans, says senior author Dr. Aitor Aguirre, an assistant professor at the Department of Biomedical Engineering of Michigan State University, in a media release.

Oxytocin stimulates erections and orgasms. In women, it is believed to help sperm reach the egg. The chemical is produced by the hypothalamus in the brain. It is secreted by the pituitary gland.Abnormal amounts have a connection to sex addiction. Oxytocin is also the foundation of many pleasurable feelings, from exercise to lovemaking.

Now, the research team reports it also causes stem cells from the hearts outer layer, or epicardium, to migrate into the middle, known as the myocardium.There they develop into cardiomyocytes, muscle cells that generate heart contractions. The discovery offers hope of promoting regeneration after damaging events like a heart attack. The cells die off in great numbers after a heart attack. Highly specialized cells dont replenish themselves.

However, previous studies have shown that a subset called EpiPCs (Epicardium-derived Progenitor Cells) can undergo reprogramming, becoming cardiomyocytes or other types of heart cells.Think of the EpiPCs as the stonemasons that repaired cathedrals in Europe in the Middle Ages, Aguirre explains.

Production is inefficient for heart regeneration in humans under natural conditions, but the humble zebrafish may hold the key. They are famous for their extraordinary capacity for regenerating organs including the brain, retina, internal organs, bone, and skin.

They dont suffer heart attacks, but predators are happy to take a bite out of any organ, since zebrafish can regrow their heart when as much as a quarter of it has been lost. This is done by proliferation of cardiomyocytes and EpiPCs. The magic bullet appears to be oxytocin.

In zebrafish, within three days after the heart was exposed to cryoinjury by freezing, expression of oxytocin in the brain soared 20-fold. Scans showed the hormone travelled to the epicardium and bound to the oxytocin receptor. This triggered a molecular cascade, stimulating local cells to expand and develop into EpiPCs.

The new cells headed for the zebrafish myocardium to develop into cardiomyocytes, blood vessels, and other important heart cells, to replace those which had been lost. Crucially, the researchers found oxytocin has a similar effect on cultured human tissue. It turned human Induced Pluripotent Stem Cells (hIPSCs) into EpiPCs.

Numbers doubled due to the hormone. None of 14 other brain hormones tested worked. The effect was much stronger than other molecules tried in mice. On the other hand, genetic engineering that knocked out the oxytocin receptor prevented the regenerative activation of human EpiPCs. The link between oxytocin and the stimulation of EpiPCs was identified in a chemical pathway known to regulate the growth, differentiation and migration of cells.

These results show that it is likely that the stimulation by oxytocin of EpiPC production is evolutionary conserved in humans to a significant extent. Oxytocin is widely used in the clinic for other reasons, so repurposing for patients after heart damage is not a long stretch of the imagination. Even if heart regeneration is only partial, the benefits for patients could be enormous, Aguirre says.

Next, we need to look at oxytocin in humans after cardiac injury. Oxytocin itself is short-lived in the circulation, so its effects in humans might be hindered by that. Drugs specifically designed with a longer half-life or more potency might be useful in this setting. Overall, pre-clinical trials in animals and clinical trials in humans are necessary to move forward.

The study is published in the journal Frontiers in Cell and Developmental Biology.

South West News Service writer Mark Waghorn contributed to this report.

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'Love hormone' oxytocin could help reverse damage from heart attacks via cell regeneration - Study Finds

Cardiac Stem Cells Comments Off on ‘Love hormone’ oxytocin could help reverse damage from heart attacks via cell regeneration – Study Finds | October 5th, 2022

Inflammatory bowel disease (IBD) is increasing around the world. In 1990, around 3.7 million people had the condition; by 2017, that number had increased to 6.8 million. Nearly half of IBD patients dont respond to current treatments, and even for the lucky ones therapeutic efficacy can wane over time. As a result, there is an urgent need to develop a new generation of IBD therapies.

Unfortunately, ineffective drug development models are hampering the search for more effective treatments. Conventional two-dimensional (2D) cell models only capture bits and pieces of IBDs complexity, and many three-dimensional (3D) culture models like organoids fall short because they lack critical biological features, such as vasculature and biomechanical forces.

Animal models have their own drawbacks, as their immune systems fail to replicate many of the mechanisms associated with human immunity.

If you look at the physiology of cardiac muscle or neurons between humans and mice, theyre fairly similar, said Christopher Carman, PhD, director of Immunology at Emulate. Theres more divergence in immunology, and it can be really challenging to extract meaningful insights around immune-system-driven mechanisms. Thats why so many therapeutics fail.

To remedy this, Emulate has developed a Colon Intestine-Chip that combines primary human tissue, vasculature, mechanical forces, and (most importantly) immune cell recruitment to recapitulate the biology that drives IBD.

UNDERSTANDING HOW IBD EVOLVES

IBD begins with an unknown tissue insult, and the body responds by producing inflammatory cytokines and chemokines. In turn, these proteins recruit immune cells to the intestine, inducing further inflammation.

This process generates a cytokine cascade. Two proteins in particular, interferon gamma (IFN) and IL-22, act directly on colon epithelial cells, driving cell death, microvilli loss, and destruction of the tight junctions that guard intestinal permeability.

That is a critical hallmark of this disease, said Carman. As a result, intestinal material, including bacteria and bacterial products, leak into the interstitial space, driving even more inflammation.

MAKING THE COLON INTESTINE-CHIP

The Emulate Colon Intestine-Chip was designed to precisely recapitulate this inflammatory cascade.

This advanced, in vitro intestine model incorporates primary human biopsy tissue cultured into organoids. Critically, the cells retain their stemness, meaning they replicate the stem cell niches that are constantly regenerating in human intestines.

After the organoids are dissociated, they are seeded in the top channel of the Organ-Chip. The bottom channel contains primary human intestine-derived microvascular endothelial cells, which are in close proximity to the epithelial cells, as they would be in vivo. The channels are separated by a porous membrane coated with tissue-relevant extracellular matrix proteins.

From there, mechanical forces on the chipphysiologic flow and cyclic stretchreplicate intestinal peristalsis, which improves cell morphology and functionality while supporting more accurate gene expression.

As a result, epithelial tissues respond to microvasculature cues, and the epithelial cells differentiate into all three major epithelial types at the appropriate ratios.

With this, the Emulate Colon Intestine-Chip is able to model IBD from the initial insult to the cytokine cascade, demonstrating along the way selective immune cell recruitment, cell death, and tight junction loss. This model can be applied to study inflammation-specific immune recruitment from vasculature into epithelial tissue and subsequent downstream impacts.

We have shown that this Organ-Chip strongly reflects what we see in primary human tissue, said Carman. It develops proper tight junctions and a strong functional barrier. On the molecular level, we see transcriptional signatures that are highly reflective of primary human tissue.

This model has demonstrated the efficacy of small molecule inhibitors that target IFN and IL-22 signaling pathways, meaning researchers can use it to validate clinically relevant drug candidates designed to prevent barrier dysfunction.

SELECTIVELY GENERATING INFLAMMATION

One of the Organ-Chips most important abilities is the selective recruitment of immune cells. This selectivity comes from tissue-specific adhesion molecules on both endothelial and immune cells, which must be highly specific to bind.

Around 30% of the bodys circulating immune cells are customized for work in the intestines. They have a molecule called 47 integrin that binds to an endothelial molecule called MAdCAM-1, which is preferentially expressed in the colon endothelium and up-regulated in response to inflammatory cues.

One of the major ways the Colon Intestine-Chip replicates IBD biology is by expressing MAdCAM-1 in response to inflammatory stimuli, giving it tremendous relevance for therapeutic discovery.

The 47 integrin/MAdCAM-1 adhesion molecule axis is an important therapeutic target, said Carman. If we can interfere with that adhesion, we can potentially interrupt the inflammatory cascade. And because this mechanism is selective to the gut, any therapeutic that targets these adhesion molecules would be highly specific to the intestinal system.

One drug, AJM300, is in phase three clinical trials right now and is showing promising safety and efficacy, said Carman. We validated that efficacy in our model. We also used the model to study the corticosteroid dexamethasone, which has been a mainstay in IBD treatment for many years. We recently published the data in an application note.

The Colon Intestine-Chip provides a more complete picture of human IBD pathogenesis, delivering a human-relevant platform to test drug efficacy. However, for Emulate, its just the beginning. Inflammation plays a major role in many conditions, and creating models that effectively replicate those pathways will be essential in validating and advancing therapeutic compounds to support better care.

This IBD model is our first foray into inflammation, said Carman. Were planning on developing many variations on this theme to create better tools for a variety of inflammation-driven indications.

For more information on Emulates IBD model, please download Modeling Inflammation-Specific Immune Cell Recruitment in the Colon Intestine-Chip.

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Recapitulating Inflammation: How to Use the Colon Intestine-Chip to Study Complex Mechanisms of IBD - Pharmaceutical Executive

Cardiac Stem Cells Comments Off on Recapitulating Inflammation: How to Use the Colon Intestine-Chip to Study Complex Mechanisms of IBD – Pharmaceutical Executive | September 27th, 2022

ONE of the most aggressive types of cancer is looking more beatable thanks to an exciting breakthrough.

Patients with glioblastoma - a fast-growing type of cancer that affects the brain and spinal cord - tend to survive just 15 months from the moment of diagnosis.

1

And currently, few successful long-term treatments are available.

But scientists at the Keck School of Medicine of USC have made a discovery that may offer real hope.

The team found that circadian clock proteins - which control our natural rhythms, like when we wake up and when we fall asleep - could be involved in the growth of glioblastoma tumours.

These proteins may also explain why people often do not remain in remission after cancer treatment, and see their glioblastoma come back.

Keck researchers identified a small molecule drug, called SHP656, that could be used to target those clock proteins and treat the devastating disease.

In the vast majority of patients, the cancer returns. And when it returns, its resistant to chemotherapy and radiation, said Professor Steve Kay at Keck.

Kay and his team believe the disease often returns because of cancer stem cells that spread fast by hijacking the bodys circadian clock mechanisms.

But SHP656 could be used to put a stop to that.

This is a potent molecule thats very exciting to us in terms of its potential for deployment against glioblastoma, said Kay.

Clinical trials are now in motion and the team hopes to begin the next phase in glioblastoma patients within two to three years.

Glioblastomas are grade 4brain tumoursand are a type of glioma, one of the most common types of primary brain tumours.

The cancer begins in the brain and almost never spreads to other parts of the body.

However, its complexity makes it difficult to treat.

There are no known causes of glioblastoma making treatment even trickier.

The first line of treatment is surgery to try and cut the tumour out.

However, it's very difficult to remove the tumour without harming healthy parts of the brain.

Chemotherapy and radiation therapy can be helpful to stop the tumour cells growing and spreading.

But despite the high intensity of the treatment, the cancer usually recurs.

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New drug could cure aggressive brain cancer stopping tumours in their tracks... - The US Sun

Spinal Cord Stem Cells Comments Off on New drug could cure aggressive brain cancer stopping tumours in their tracks… – The US Sun | September 27th, 2022

- CRC data on cord lining media for the treatment of diabetic foot ulcers has been accepted at the DFCon, with Dr Wong Keng Lin Francis, CRC's latest KOL, presenting his findings to world leaders in the field of DFU.- Similarly, the results of Corlicyte's Phase 1 study on the treatment of chronic diabetic foot has also been accepted with the presentation being given by Dr Cecilia Low-Wang, the trials Principal Investigator.- DFCon is a global specialist multi-disciplinary congress that attracts specialists in the field of the diabetic foot and is considered the most influential event in the industry. It is co-founded by Dr David Armstrong, a pre-eminent expert in diabetic foot.- Dr Armstrong, who also serves on CRC's scientific advisory board, will be giving the opening address for CRC's breakfast symposium on their lead products Sollagen and Corlicyte.- CorLiCyte is an umbilical cord lining stem cell therapy, for patients suffering with diabetic foot ulcers (DFU), Sollagen is a brand targeting diabetic's skin.- Global diabetes patient population is set to grow from 537 million in 2021 to 783 million in 20451- DFU is a global health emergency that will affect close to 20% of the diabetic population in their lifetime

LOS ANGELES, Sept. 26, 2022 /PRNewswire/ -- CRC is delighted to announce attendance at DFCon, the global specialist multidisciplinary congress focused on the diabetic foot held in late September 2022 in Los Angeles, USA. The meeting is a gathering of a wide range of both generalists and specialists who diagnose and manage diabetic feet, to discuss best practice in diagnostics and interventions for both treatment and amputation prevention. It was co-founded and is co-chaired by Dr David Armstrong, a pre-eminent expert in diabetic foot who also serves on CRC's scientific advisory board.

Dr David Armstrong will be introducing CRC's headline symposium on Saturday morning where Dr Paul Kemp, the inventor of Apligraf and scientific advisory board member, and esteemed researchers Dr Brian Freed and Dr Wong Keng Lin Francis will present an overview of CRC's technology and data.

Furthermore, CRC have two scientific posters approved for presentation at DFCon on the data generated in Corlicyte and Sollagen:

The first poster "Results of the phase 1 open-label safety study of umbilical cord lining (Corlicyte) to heal chronic diabetic foot ulcers" details the Phase I study in Corlicyte and is authored by Cecilia Low Wang and the team from the University of Colorado who conducted the study.

The second poster by Dr Wong from Sengkang General Hospital/Duke NUS is titled "Early evaluation of Sollagen, a topical exosomal skin conditioner derived from Umbilical cord lining cell media, in treatment of persistent chronic DFU" and details the impressive early data generated with Sollagen in chronic diabetic foot ulcers.

Both posters are a testament to the immense potential of Corlicyte and Sollagen for the treatment of diabetic foot ulcer, a huge issue for patients and health care systems alike.

CRC's presence at such a specialized and well-regarded scientific and medical forum reflects the exciting data the company is generating. It is a strong indication of the academic and clinical network that the company is building to deliver products that can make a dramatic difference to patients with a large unmet medical need.

About CellResearch Corporation (CRC)

CellResearch Corporation was founded in 2002 as a contract research provider focusing on skin cells. In 2004, the company made the discovery that the umbilical cord lining of mammals was an abundant source of both mesenchymal and epithelial stem cells. Today, the company owns this technology through a family of patents and holds the rights to commercialize this technology in most major markets globally. While the closure of diabetic foot ulcers is the company's first allogeneic therapy to make it to the end of Phase 1 USFDA clinical trials, CellResearchCorp has a broad therapeutic pipeline at the pre-clinical stage. Further therapies include solid tumor therapy, inflammatory diseases, cardiac muscle repair, Parkinson's Disease, Age-related Macular Degeneration and Diabetes.

CellResearch Consumer Health, a wholly owned subsidiary of CellResearch Corp, is the commercialization vehicle for CALECIMProfessional and the newly launching Sollagen. It produces an innovative range of skincare and haircare products using cord lining stem cell media to power its products. It is used in clinics/hospitals and as part of an at-home anti-aging skincare regime. It is distributed globally through over 600 aesthetic physicians and online via their own website. It has a key distribution partnership with Menarini Group across Southeast Asia.

CellResearch Corp partner, Cordlife offers parents the opportunity to bank their child's umbilical cord tissue alongside their cord blood. Cordlife has what is believed to be the largest licensed bank of umbilical cord tissue globally. As cell therapies move into the clinic, Cordlife will have the ability to expand stem cells from a banked umbilical cord for autologous and donor-related uses.

http://www.cellresearchcorp.com

https://calecimprofessional.com

Business Development and Investor Relations:

Xavier Simpson

+65 8815 6139

xaviersimpson@cellresearchcorp.com

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CellResearch Corporation (CRC) to present promising new stem cell products for the treatment of chronic diabetic foot ulcers at the world's premier...

Skin Stem Cells Comments Off on CellResearch Corporation (CRC) to present promising new stem cell products for the treatment of chronic diabetic foot ulcers at the world’s premier… | September 27th, 2022

A new approach is paving the way for improved stem cell therapies and regenerative applications using cells from pigs. Led by Wan-Ju Li, a SCRMC researcher and associate professor in the Department of Orthopedics and Rehabilitation and the Department of Biomedical Engineering, this new study published in Scientific Reports offers a viable strategy to enhance the generation of induced pluripotent stem cellsfrom large animal cells and provides researchers with insight into the underlying mechanism controlling the reprogramming efficiency of cells. In turn, this approach will allow researchers to reprogram cells more efficiently into iPSCs which can be used to study regenerative therapies aimed at treating everything from osteoarthritis to heart disease.

While this approach can be applied to regenerative therapies targeting any organ or tissue, Li and his Musculoskeletal Biology and Regenerative Medicine Laboratory study cartilage, so he developed the model by deriving iPSCs from the fibroblast cells of three different breeds of miniature pigs including Wisconsin miniature swine, Yucatan miniature swineand Gttingen minipigs. Fibroblast cells are easily obtained for cellular reprogramming and Li is interested in using these cells to efficiently develop cartilage cells that can be used to help patients experiencing osteoarthritis. But, while his goal for the study was specific, the model has wide-reaching implications.

"This model we created can be used for many applications," says Li. "In successfully developing iPSCs from three different breeds of minipigs, we learned we can take somatic skin cells from these pigs that we programmed ourselves into iPSCs and then inject them back into the same animal to treat the disease. Or we can take the cell that carried the disease gene and put that into the culture dish and use that as a disease model to study disease formation."

Li explained that iPSCs can be created from nearly any type of somatic cell, such as skin or blood cells, that are reprogrammed back into an embryonic-like pluripotent cells. These pluripotent stem cells are the bodys master cells and are, therefore, able to become nearly any cell in the body. Harnessing the power of such a cell and being able to grow these versatile cells in the lab is invaluable to medicine as these cells can be used for the regeneration or repair of damaged tissue and in drug testing to see how medication will impact heart, liver, or other cells within the body.

Through this research, Li and his lab have provided researchers with insight into the underlying mechanism controlling the reprogramming efficiency of iPSCs, allowing researchers to harness to power of iPSCs and develop them more efficiently. Specifically, he discovered that the expression level of the switch/sucrose nonfermentable component BAF60A, which is essentially a protein that can remodel the way DNA is packaged, helps to determine the efficiency of iPSC generation. He also noted that the BAF60A is regulated by STAT3, a transcription factor protein that plays a role in cell growth and death. Through this, Li discovered that the efficiency of iPSC generation is based on the expression level of these proteins and that the expression levels vary among pig breeds.

"While we successfully developed iPSCs and programmed iPSCs from the three different strains of pig, we noticed that some pigs had a higher reprogramming efficiency,"says Li. "So, the second part of our findings, which is significant in biology, is understanding how these differences occur and why."

Li shared that understanding why different pig breeds have varying levels of reprogramming efficiency will directly translate to understanding differences in the effectiveness of iPSC generation between individual humans. In fact, a previous study by Mackey et al., has shown that a person's ethnicity may impact their cell's reprogramming efficiency. So, understanding what mechanisms control cellular reprogramming will be crucial to developing effective protocols of iPSC generation for individualized therapies.

"With this model, we can study musculoskeletal regeneration particularly cartilage regeneration for osteoarthritis patient,"says Li. "But we think the impact is way beyond the application of orthopedics because from now on, anybody on campus who is interested in using the technology we have developed for a minipig model, can reprogram their cells into iPSCs and then these cells and the animal can be used to investigate heart disease, kidney disease, neuronal diseaseor any type of a disease."

Translating this research to improve human health, is deeply important to Li. He has spent much of his career studying novel approaches to regenerate cartilage and bone for orthopedic applications and developing a translational model like this means that science is one step closer to healing more patients using stem cells.

"I feel really touched by the stories people share. You cannot imagine how many emails come in asking me if they can become the first human patient in our future clinical trial,"Li says. "People are in desperate need for something, especially when those people feel the current surgical procedure or intervention is not suitable for them. I have to keep saying, 'wait for another two, three years, maybe we'll be ready for a clinical trial,'but for me, it's time to move on and really do our larger animal studies to fulfill our promise. At least that way, I can fill the gap between the lab and clinical trials as the larger animals must be studied before you go into a clinical trial."

Li's development of a reliable and translational model for the generation of iPSCs in a large animal is critical as it has been a challenge to generate pig iPSCs with efficiency. The reprogramming efficiency of pig cells is relatively low compared to that of human or mouse cells, but large animal studies remain a crucial step in bringing treatments to clinical trials.

Interest in moving these treatments forward has grown and while this study was funded in part by NIH, Li also received support from the Plunkett Family Foundation in Milwaukee through their donation to the UW Stem Cell and Regenerative Medicine Center. After hearing of Li's research, Gwen Plunkett and her daughter Karen visited Li and his lab in 2019 to learn more and were inspired to support research into stem cells for cartilage regeneration.

"Innovation in medicine sparks critical change, for the world and the survival of our species and the Plunkett Family mission is to be a catalyst in stem cell and regenerative medicine research,"says Karen Plunkett. "We supported Jamie Thomson's lab in the early days when federal funding for human stem cell research was restricted. More recently, we continued our commitment to this research by supporting Dr. Wan-Ju Li's stem-cell based approaches for regenerating skeletal tissues, cartilageand bone for orthopedic applications. Additionally, it is personally gratifying to be able to support the SCRMC while my son completes his senior year studying neurobiology at UWMadison.We are happy to be part of the University of Wisconsin family."

Li shared that the donation was profoundly impactful and allowed him to further his goal of using stem cells to help patients struggling with osteoarthritis as well as other joint diseases.

"I want to make sure that our findings in stem cell research can be used to help people,"says Li. "I just feel this internal drive to study this area and I feel good knowing this model carries significant weight in terms of its potential for translational stem cell research and the development of therapeutic treatments."

This research was supported by grants from the National Institutes of Health (R01 AR064803) and the Plunkett Family Foundation. The UW Department of Pathology and Laboratory Medicine and UWCCC (P30 CA014520) and the Small Animal Imaging andRadiotherapy Facility and Flow Cytometry Laboratory, supported by UWCCC (P30 CA014520) also provided facilities and services.

Source: University of Wisconsin-Madison, whichis solely responsible for the information provided, and wholly owns the information. Informa Business Media and all its subsidiaries are not responsiblefor any of the contentcontained in this information asset.

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Reprogramming pig cells leads way for new regenerative therapies - National Hog Farmer

Skin Stem Cells Comments Off on Reprogramming pig cells leads way for new regenerative therapies – National Hog Farmer | September 27th, 2022