International
INTERNATIONAL TRIALS
Stemedica International SA is actively engaged in supporting pre-clinical and clinical trials around the world where our products are being used.
Through geographically exclusive Distributor Agreements and several Strategic Partnerships with major companies worldwide, Stemedica International SA is providing products, protocol support and expertise in the storage, handling and administration of Stemedica product to advance pre-and clinical trials for medical indications of mutual interest.
Through these relationships, Stemedica International SA is also developing contractually based associations with a select number of highly accredited hospitals and clinical research centers around the world. Fully evolved, these relationships will eventually provide qualified patients with first access to safe, alternative treatment for conditions and diseases for which no other therapy is available.
In order to qualify for use of Stemedica product, each hospital and clinical research center must meet the following stringent requirements:
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Government regulatory approval for the importation and transplantation of allogeneic adult stem cells.
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Approval from internal oversight committees. (Usually IRB & Ethics Committees)
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Establish a dedicated laboratory for cell processing, storage and preparation.
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Comply with Internationally recognized patient education & advocacy rights.
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Complete training, and implement standard operating procedures and protocols for all facets of product management and transplantation.
Under these strict guidelines and oversight, Stemedica International SA is currently supporting clinical trials in Kazakhstan and Mexico and anticipates supporting similar initiatives in Argentina, Panama, Lebanon, Jordan, India, and Korea in 2012.
The company's International subsidiary is also supporting significant pre-clinical trials in Russia, Switzerland, China, and Korea.