The biotech company Stemedica Cell Technologies has requested a pre-IND (investigational new drug) meeting with the U.S. FDA (Food and Drug Administration) for the purpose of discussing the use of Stemedica’s proprietary line of allogeneic adult stem cells as treatment for ischemic stroke.
Specializing in the R&D of adult stem cell therapies, Stemedical Cell Technologies has developed proprietary products composed of the type of adult stem cell known as mesenchymal stem cells (MSCs), which have already been shown in a number of independent studies to constitute a safe and efficacious therapeutic modality for a wide variety of injuries and diseases.
According to Nikolai Tankovich, M.D., Ph.D., president and chief medical officer of Stemedica, "Following a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy. Treatment with allogeneic mesenchymal bone marrow cells may offer new hope to patients with chronic neurological or age-related, neurodegenerative diseases." Indeed, since MSCs are known to be "immune privileged", "universal donor" cells, they pose no risk of immune rejection and therefore do not need to be administered autologously (in which the donor and recipient are the same person) but instead can be administered allogeneically (in which the donor and recipient are not the same person), as an "off-the-shelf" item.
The requested pre-IND meeting with the FDA is the preliminary step in the formal authorization process required before clinical trials can be initiated. According to Maynard Howe, Ph.D., vice chairmand and CEO of the company, "Stemedica’s facility will manufacture clinical grade stem cells as it prepares for FDA approval of an IND to begin clinical trials."
Incorporated in 2005 and headquartered in San Diego, Stemedica describes itself as a "specialty biopharmaceutical company" which, within the U.S., is "currently developing regulatory pathways for traumatic injury, stroke and wound repair." As further described on the company’s website, "Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair."