Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it has filed an Investigative New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial. The trial will assess the safety, tolerability and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.
The proposed clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with significant functional or neurologic impairment related to the ischemic stroke that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living. The proposed trial will take place at medical centers within the United States.