What do we know of the safety and efficacy of stem cell therapeutics? Over 50 years have passed since the discovery of hematopoietic stem cells (bone marrow transplantation to cure diseases such as leukemia), over 24 years since the discovery of human embryonic stem cells (hESC), and 18 years since the discovery of induced pluripotent stem cells (iPS cells). There are now thousands of stem cell trials underway in clinics worldwide. Despite this experience, what do we actually know about the safety and efficacy of stem cell therapeutics? [Read more…]
FDA Grants RMAT to iRegene’s NouvNeu001, Making It World’s First iPSC Therapy with FTD and RMAT Recognitions
Designation underscores potential of chemically induced, off-the-shelf cell therapy to address high unmet need in Parkinson’s disease, following compelling Phase I clinical data
CHENGDU, China, Jan. 19, 2026 — iRegene Therapeutics Co., Ltd. (“iRegene” or the “Company”), a biotechnology company pioneering chemically induced allogeneic cell therapy, today announced that its lead product, NouvNeu001, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease (PD). [Read more…]
I Peace Announces Successful Generation of Human iPS Cells from NKT Cells and Commences Their Availability
February 6, 2026 – Palo Alto, CA – Leading GMP cell therapy CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that it has successfully generated human induced pluripotent stem (iPS) cells from NKT cells and has begun offering them for research use. NKT cells are immune cells known to possess characteristics of both innate and adaptive immunity and to play important roles in cancer, infectious diseases, autoimmune disorders, and other conditions. The establishment of iPS cells derived from NKT cells is expected to significantly advance research in regenerative medicine and cancer therapy based on immune mechanisms. [Read more…]
Takara Bio Establishes Foothold in the Pluripotent Stem Cell Market
A few years back, Takara Bio 
announced that the Medical Products Agency (“MPA”), the Swedish national authority responsible for regulation of drug and medical products, had granted the company a manufacturing license for derivation and banking of human embryonic stem (hES) cells to be produced under GMP conditions. The cells were to be produced at Takara Bio’s manufacturing laboratory located in Göteborg, Sweden, within Takara Bio Europe’s facility.
This announcement made Takara Bio the first company worldwide to offer this service for human ESCs.
Takara Bio’s Role with Human Pluripotent Stem Cells
The significance of this event is that Takara Bio is capable of providing a predictable and reliable source of hES cells for future cellular therapeutic development by sourcing starting material from FDA-compliant facilities, according to FDA guidelines and leveraging its proprietary, feeder-free hES cell establishment method, which is animal- and human-component free. [Read more…]
Top iPSC Providers Transforming Preclinical Safety for Big Pharma
The pharmaceutical industry continues to grapple with preclinical and clinical safety issues, with toxicity remaining a leading cause of drug failure. Cardiovascular toxicity, in particular, stands out, accounting for approximately 40% of all drug withdrawals due to safety concerns. To mitigate these risks, human induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) have emerged as a critical tool for evaluating cardiac safety. Traditionally, most studies have relied on iPSC-CMs from one or two healthy donors, limiting the representation of broader population variability in drug response. [Read more…]
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