Stemedica Cell Technologies has requested a pre-Investigational New Drug (IND) meeting with the FDA. The purpose is to discuss a proposed IND to use Stemedica’s proprietary line of allogeneic mesenchymal bone marrow cells as a treatment for ischemic stroke.
Nikolai Tankovich, president and chief medical officer of Stemedica, said: 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.
The company said that the allogeneic mesenchymal bone marrow cells are obtained from donors by extracting bone marrow and are expanded at Stemedica’s cGMP compliant facility, which is licensed by the California Department of Public Health, Food and Drug Branch.
Maynard Howe, vice chairman and CEO of Stemedica, said: Stemedica’s facility will manufacture clinical grade stem cells as it prepares for FDA approval of an IND to begin clinical trials.