Stemedica Begins First Clinical Trials In The U.S. Using Adult Allogeneic Stem Cells To Treat Alzheimer’s Disease
SAN DIEGO, California, and Lausanne, Switzerland — July 27, 2016 — Stemedica and its subsidiary, Stemedica International S.A., a leader in the development of innovative stem cell-based treatments for Alzheimer’s disease (AD), are pleased to announce the opening of enrollment into a new study at Emory University in Atlanta and University of California, Irvine (UCI). The study is 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.”
“This study is based on exciting preclinical data which demonstrated that intravenous administration of Stemedica stem cells resulted in a delay of accumulation of plaque formation and also in the reduction of plaque in an animal Alzheimer’s model. This exciting data has been presented at several international meetings,” says Lev Verkh, PhD, chief regulatory & clinical development officer at Stemedica. “We are also encouraged by an excellent safety profile of our cells as demonstrated in several ongoing clinical trials conducted by Stemedica and Stemedica affiliates under U.S. Investigational New Drug (IND).”
“As we begin the enrollment process at Emory and UCI, we get closer to reaching our vision for an effective treatment for this devastating disease,” says Nikolai Tankovich, MD, PhD, president and chief medical officer of Stemedica Cell Technologies and executive chairman of Stemedica International.
About Stemedica
Stemedica is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke, traumatic brain injury and Alzheimer’s disease. Stemedica products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California and can be found online at www.stemedica.com.
About Stemedica International S.A.
Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease and vascular dementia. The company is a subsidiary of Stemedica a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has the worldwide rights to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability.