Stemedica Cell Technologies
Stemedica Cell Technologies Employees
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David M. McGuigan
Executive Vice President, Strategy & Business Development
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Lev Verkh
Chief Regulatory and Clinical Development Officer
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Marcie Frank
Senior Vice President, Corporate Administration & Investor Relations
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Stemedica Cell Technologies' Overview
Stemedica Cell Technologies is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of progenitor cell and protein therapeutics. The company focuses on treating underserved medical conditions through innovative therapies, particularly ischemia-tolerant mesenchymal stem cells (itMSCs) and ischemia-tolerant neural progenitor cells (itNSCs). Their proprietary manufacturing technology platform, which operates under a low-oxygen, low-tension environment, is cGMP-compliant and designed to produce allogeneic progenitor cell products with robust intellectual property protection.
Stemedica Cell Technologies' Lead Drug Candidates
Stemedica's lead drug candidate is ischemia-tolerant mesenchymal stem cells (itMSCs), an allogeneic progenitor cell therapy. This therapy is currently in clinical development for treating ischemic stroke and Alzheimer’s disease. Another significant candidate is ischemia-tolerant neural progenitor cells (itNSCs), an allogeneic cell therapy aimed at spinal cord injury. Additionally, the company is developing progenitor multi-cell therapy, combining itMSCs and itNSCs for ischemic stroke, and progenitor cell and protein combination therapy for Alzheimer’s disease. These therapies are designed to address critical unmet medical needs and improve patient outcomes.
Stemedica Cell Technologies' Manufacturing and Compliance
Stemedica's manufacturing facility is located in San Diego, California, and is compliant with current Good Manufacturing Practices (cGMP). The facility is licensed by the California State Department of Public Health Food and Drug Branch (FDB) to produce cells for human clinical trials. The company employs a proprietary low-oxygen, low-tension environment to manufacture its progenitor cells, enhancing their ischemia tolerance, immune privilege, and therapeutic efficacy. This innovative approach ensures that the cells are of the highest quality for clinical applications.
Stemedica Cell Technologies' Partnerships and Distribution
Stemedica collaborates with various geographic distributors to conduct clinical trials approved by international regulatory agencies. The company also supplies progenitor cells for research through its exclusive distribution partner, ThermoFisher Scientific. These partnerships enable Stemedica to extend its reach globally, ensuring their cell products are utilized in FDA-approved clinical trials in the U.S. and other trials worldwide. This strategic distribution network helps the company maintain a robust presence in the biopharmaceutical industry.
Stemedica Cell Technologies' Intellectual Property
Stemedica boasts a robust patent portfolio, with several issued patents and pending applications in the United States Patent and Trademark Office. This extensive intellectual property protection underscores the company's commitment to innovation in progenitor cell and protein therapeutics. By safeguarding its proprietary technologies, Stemedica ensures a competitive edge in the biopharmaceutical market, fostering continued research and development in its therapeutic areas.