Tuesday, August 14, 2012
Stemedica International Receives Licenses from Swissmedic for Import and Export of its Stemedyne™ Stem Cell Line
Stemedica International, SA (Epalinges, Switzerland), a wholly owned subsidiary of Stemedica Cell Technologies, Inc. (“Stemedica”), a leader in adult stem cell research and manufacturing, announced today that it has been granted a series of licenses by Swissmedic (the Swiss equivalent of the United States Food and Drug Administration). These licenses specifically authorize the Company to import and export its Stemedyne™ stem cell products worldwide for human use in approved clinical trials.
Granting of the license by Swissmedic marks the culmination of a two-year inspection process of Stemedica’s United States and Swiss operations. The Swiss government’s rigorous inspection and approval process has included: (1) a comprehensive, in-depth audit of Stemedica’s processes and procedures; (2) the examination of Stemedica’s quality systems; and (3) interviews with facility management and onsite inspections of the facilities.
Stemedica currently produces two lines of ischemia-tolerant adult allogeneic stem cell products. These include Stemedyne™-MSC, bone marrow derived mesenchymal stem cells and Stemedyne™-NSC, neural stem cells. A third product, Stemedyne™ Retinal Pigment Epithelium (RPE) stem cells is currently in development. Stemedica now has full regulatory approval from the Swiss government to provide these cells to countries that can legally import them for the purpose of conducting clinical trials. Stemedica’s immune-privileged stem cells have been approved and are being used in clinical trials in the United States and in multiple countries.
Dr. Nikolai Tankovich, M.D., Ph.D., Chairman of Stemedica International, noted the significance of the Swiss approval, “Swiss safety regulations are among the most stringent in the world. We are pleased to be recognized for the relentless attention we place on creating cells with the highest standards for safety, purity, potency and scalability.”
According to Maynard A. Howe, PhD, CEO and Vice Chairman of Stemedica USA, “The Swiss government’s approval positions Stemedica International as one of only a few companies worldwide with broad-based regulatory compliance. Our Swissmedic licenses, coupled with the US Food and Drug Administration (FDA) investigational new drug approval for our mesenchymal stem cells, provides assurance to regulators, hospitals, physicians, and patients, that Stemedica products meet the most rigid specifications.”
Stemedica’s manufacturing process is in full compliance with current good manufacturing processes (cGMP) requirements in that there is full traceability for every batch lot released by the company.
Earlier this year, Stemedica International, along with its academic partner, The École Polytechnique Fédérale de Lausanne (EPFL) was awarded a $620,000 grant by the Swiss Commission for Technology and Innovation to study the use of optical coherence microscopy for functional label free imaging of brain perfusion and size/number of beta-amyloid plaques with Stemedyne™ neural and mesenchymal stem cells in an animal model for Alzheimer’s.
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About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.