NANJING, China, Oct. 22, 2024 — HELP Therapeutics Co. Ltd, a clinical-stage cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for “Allogeneic Human iPSC-derived cardiomyocytes (HiCM-188) administered via intramyocardial injection during coronary artery bypass graft surgery.” [Read more…]
Altucell Releases Evidence in Support of Microencapsulated Sertoli Cells for Reversal of Diabetes
Diabetes is a chronic disease that both reduces life expectancy and reduces quality of life among the afflicted.
According to the Center for Disease Control (CDC), 29.1 million people or 9.3% of the U.S. population has diabetes, including an estimated 8.1 million who are undiagnosed. According to the American Diabetes Association, the “2012 cost of this disease in the U.S. was $245 billion per annum or approximately $500,000 every minute.”
Additionally, nearly 90% of those patients are afflicted by type 2 or “insulin resistant” diabetes. Specifically, the World Health Organization (WHO) estimates that 90% of people around the world who are afflicted by diabetes suffer from type 2 diabetes.
Therefore, progress with a cell therapy based approach for the treatment diabetes would represent a global medical breakthrough. [Read more…]
AABB Introduces New Cell and Gene Therapy Standards for Pharmacy
Oct 16, 2024, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to introduce the proposed first edition of Cell and Gene Therapy Standards for Pharmacy, available for public comment through Dec. 16. These new standards represent an important advancement in ensuring the highest level of quality and safety for cell and gene therapy (CGT) products.
As more and more CGTs gain approval, pharmacies are becoming key players in managing these complex, high-value therapies. A review of existing pharmacy quality programs and available certifications revealed a lack of standards for handling and managing CGTs within pharmacy. [Read more…]
Top 5 TED Talks About Stem Cells
Check out the best TED Talks below to understand the growing importance of stem cells within regenerative medicine.
In this article:
I Peace announces new iPSC lines to reduce immune rejection risk for U.S. population
More than 100 million people in the U.S. have this HLA-A haplotype
October 30, 2024, Palo Alto, CA – Leading G.M.P. cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the company has successfully generated iPS cell lines that are homozygous for HLA A, C, and DPA1. Two clonal lines are available for cell therapy developers and pharmaceutical companies as off-the-shelf products in both G.M.P. and research-grade. [Read more…]
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