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Stemedica Advances its Certification to Become a Licensed Manufacturer of Adult Stem Cells for U.S. Based Clinical Trials
Date:2/25/2009

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, 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 l
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Stemedica Advances its Certification to Become a Licensed Manufacturer of Adult Stem Cells for U.S. Based Clinical Trials 
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