NexCell Scientific Inc
FDA issued a warning letter to NexCell Scientific Inc (Irvine, CA) after inspections in December 2025 and February 2026 found the company was manufacturing and distributing an umbilical cord blood-derived total nucleated cell (TNC) product for allogeneic use without an approved Biologics License Application (BLA) or Investigational New Drug (IND) application, constituting an unapproved new drug and unlicensed biological product in violation of the FD&C Act and PHS Act. The company's website and a referenced white paper made claims that the product could treat inflammation, musculoskeletal disorders, neurological conditions, autoimmune diseases, and other serious conditions. FDA also documented seven significant CGMP violations including unvalidated manufacturing and aseptic processes, failed sterility tests without root-cause investigations, and absence of an independent quality control unit. The letter warns that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (6)
Several research studies suggest that umbilical cord-derived allografts may have potential advantages for a range of indications, such as musculoskeletal disorders, modulation of immune responses, neurological conditions, liver cirrhosis, cardiovascular system issues, blood disorders, wound, and multiple variants of systemic or autoimmune disorders.
Once in the affected area, the cells … begin to produce signaling proteins that work to regulate inflammation, aid in angiogenesis, and promote tissue repair.
Because of their ability to differentiate into cells that carry out the roles needed in a variety of organs, cell allografts are an essential regenerative tool. When these allografts are introduced into a damaged tissue or organ, they have the ability to evolve and carry out necessary functions, compensating for the damaged cells.
When injected into a damaged tissue, the cells specialize to carry out the necessary function of that particular area, improving symptoms and function.
Research suggests that the use of mesenchymal and hematopoietic stem cells may offer potential benefits for musculoskeletal issues, wound injuries, cirrhosis of the liver, blood disorders, cardiovascular conditions, neurological disorders, and systemic and autoimmune diseases. A number of clinical trials have specifically targeted autoimmune issues, including multiple sclerosis, psoriasis, Crohn's disease, rheumatoid arthritis, lupus erythematosus, and others.
[Mesenchymal stem cells] reduce the signal cells that promote inflammation… While this is another function that helps them avoid the immune response, it is also essential to the cells' utility in chronic and autoimmune disease characterized by inflammation.
Required actions (3)
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
Your response does not address your continued distribution of your product or specific plans for disposition of the remaining inventory manufactured under the violative conditions outlined above.
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