FDA Approves Stemedica’s Phase 2a Alzheimer’s Therapy Study

FDA Approves Stemedica’s Phase 2a Alzheimer’s Therapy Study
The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Stemedica Cell Technologies, Inc. The approval means that the company is allowed to initiate a phase 2a clinical study to evaluate the use of an allogeneic stem-cell therapy for the treatment of patients with mild to moderate dementia related to Alzheimer's disease. Stemedica announced that it will initiate the study entitled "A Phase IIa Multicenter, Randomized, Single-blind, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer's Disease," following the FDA approval. The research, which is expected to result in an effective treatment to address Alzheimer's will take place at the University of California, San Diego (UCSD) under Principle Investigator Douglas Galasko, MD. The company also stated that it is planning to extend the study to further clinical sites and that it will be conducted with financial support and management assistance from Stemedica International, S.A. "We are very excited to take this next
Subscribe or to access all post and page content.