Stemedica Advances its Certification to Become a Licensed Manufacturer of Adult Stem Cells for U. S. Based Clinical Trials
Stemedica Cell Technologies, Inc. announced today that it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for U. S.-based Phase I and Phase II Clinical Trials.
San Diego, CA (PRWEB) February 25, 2009
Stemedica Cell Technologies (http://www. stemedica. com), Inc. ("Stemedica") announced today that it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for U. S.-based Phase I and Phase II Clinical Trials. Readiness for manufacture includes obtaining a California Drug Manufacturing License for the Stemedica facility in San Diego, California.
"Completion of this certification will allow us to manufacture stem cells under contract for clinical trials for Stemedica as well as for other companies and research centers in California and across the United States. This marks a significant milestone along the journey toward the future availability of stem cell treatment for patients who so urgently need it," said Dr. Maynard Howe, Vice Chairman and CEO at Stemedica.
To prepare for inspection, Stemedica fully reconstructed its facility according to FDA requirements, which had previously focused on research and development. Stemedica's manufacturing facility now includes a fully compliant manufacturing wing with entry-level gowning rooms, two ISO class 8 sterile gowning suites, an ISO Class 7 Manufacturing Clean Room, an ISO Class 7 Processing Clean Room, a Good Manufacturing Process compliant materials warehouse and a controlled-access Quality Control testing laboratory.
"As soon as Stemedica secures its license from the State of California's Department of Public Health, we plan on filing for one or more IND's (Investigative New Drug) for specific indications with the FDA using our proprietary technology. The final major step by the Food and Drug Branch within the Department of Public Health is an in-depth, in-person inspection by their personnel. We're particularly proud of the fact that we are ready for, and capable of, seeking licensing in California, which has exceptionally stringent standards," said Dr. Alex Kharazi, Vice President, Research & Manufacturing at Stemedica.
"Becoming a Licensed Manufacturer of clinical grade adult stem cells is a significant scientific and medical step forward for the Company," said Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer. "Securing this status will allow us to become a primary CMO (Contract Manufacturing Organization) for other for-profit companies and the many research organizations interested in advancing stem cell research through clinical application. Additionally, achieving this regulatory status within the manufacturing world will provide Stemedica with the foundation to advance its own Phase I and Phase II Clinical Studies once approved by the FDA."
About Stemedica Technologies, Inc.
Stemedica Cell Technologies Inc. (http://www. stemedica. com (http://www. stemedica. com)) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.
Media Contact for Stemedica: Dave McGuigan -- dmcguigan (at) stemedica. com.
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