In a significant advancement for regenerative medicine, BioRestorative Therapies, Inc. has secured a provisional license from the New York State Department of Health (NYSDOH) to process allogeneic (non-autologous) donor tissue material, including stem cells, for medical research.
This expansion builds upon their previous authorization, which was limited to autologous (self-donated) mesenchymal stem cells.
This new license empowers BioRestorative to utilize its cutting-edge cGMP manufacturing facilities for the processing, banking, and distribution of clinical-grade allogeneic (off-the-shelf) biologics.
Such capabilities are crucial for advancing stem cell-based therapies and broadening the scope of regenerative treatments.
The NYSDOH’s licensure process is rigorous, ensuring that all tissue and cell-related activities, including collection, processing, storage, and distribution, meet stringent safety and ethical standards.
Facilities undergo comprehensive on-site evaluations to assess compliance with these regulations.
Lance Alstodt, CEO of BioRestorative Therapies, remarked, “We believe being awarded this expanded provisional license from the NYSDOH serves as a testament to both the ground-breaking nature of our clinical work with stem cell therapies and products, and the outstanding quality of our clinical-grade cell therapy cGMP manufacturing facility.”
This development positions BioRestorative to enhance its clinical pipeline of off-the-shelf cell-based biologic products, potentially accelerating the availability of innovative treatments for patients.
BioRestorative’s core programs include the brtxDISC™ program, focusing on autologous mesenchymal stem cell therapy for lumbar disc disorders, and the ThermoStem® program, targeting obesity and metabolic disorders through brown adipose-derived stem cells.
Additionally, the company offers BioCosmeceutical products, utilizing cell-based secretomes for cosmetic applications.
This expanded license marks a pivotal step in BioRestorative’s mission to advance stem cell research and develop transformative therapies for various medical conditions.