Stemedica Cell Technologies, Inc., a world leader in adult stem cell manufacturing and research, announced today that it has completed its proprietary master bank of mesenchymal bone marrow-derived stem cells. The master cell bank was manufactured in accordance with FDA Good Manufacturing Practices (cGMP).
The cell bank has successfully passed all the necessary safety testing required by the FDA and is in compliance with the U.S. Code of Federal Regulations. Stem cells from the master bank will be used to support clinical trials in the United States and worldwide. The master bank together with its parent bank has the capacity to treat up to 300,000 patients participating in approved clinical trials.
The master bank has been created at the Company’s San Diego cGMP manufacturing facility, which is licensed by the State of California’s Department of Public Health, Food and Drug Branch to produce stem cells, drugs and biologic products for human clinical trials.
Stem cells from the master bank will be used in the Company’s current FDA-approved clinical trial for ischemic stroke in the United States. There are over 750,000 strokes each year in the United States resulting in 160,000 deaths. In addition, there currently is no treatment option available for the thousands that are left with severe disabilities.
“Stemedica’s stem cells will also be provided to sites in various countries that have already received regulatory approval to conduct clinical trials using Stemedica’s products,” stated, Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “We have a pending Investigational New Drug application to conduct a clinical trial outside the United States for vascular dementia, the most common form of dementia. Alzheimer’s represents a subgroup of this condition. Researchers in the United States will now have access to Stemedica stem cells for preclinical studies; cells with predictability and reproducible potency.”
“This is a significant milestone in fulfilling our Company’s commitment to provide stem cells for clinical trials designed to help people suffering with medical conditions for which there are no other options,” said Maynard Howe, PhD, Stemedica’s Chief Executive Officer. “We will now be able to supply our proprietary stem cells to our research and clinical trial partners worldwide.”
The Company is in the process of developing master and parent cell banks for additional stem cell lines including neural cells and retinal pigment epithelial cells produced for human use. Management believes that these master cell and parent cell banks are essential to meet the growing demand for stem cell products worldwide.
SOURCE Stemedica Cell Technologies, Inc.