FOR IMMEDIATE RELEASE
FDA Approves GIOSTAR’s Landmark Clinical Trial for Autologous Stem Cell Treatment with Crucial Support from FDAMap
FDAMap provided end-to-end support, including protocol design, IND submission, and GMP setup, for GIOSTAR’s FDA-approved diabetes trial.
Gaithersburg, MD – November 2024 – FDAMap proudly congratulates GIOSTAR (Global Institute of Stem Cell Treatment and Research) on receiving FDA approval for their first clinical trial in the U.S. for an autologous stem cell treatment targeting diabetes. This groundbreaking development represents a significant advancement in diabetes research and reflects GIOSTAR’s commitment to innovative and transformative healthcare solutions.
FDAMap, a full-service CRO specializing in end-to-end and fully in-house clinical trial support played a pivotal role in this achievement. From designing the clinical trial protocol to preparing and submitting the Investigational New Drug (IND) application, FDAMap ensured GIOSTAR met every critical milestone. Additionally, FDAMap established GMP manufacturing operations to produce the therapy, ensuring the highest standards of quality and compliance for the upcoming clinical trial.
The clinical trial, which will also be conducted under FDAMap’s management, aims to evaluate the safety and efficacy of GIOSTAR’s autologous stem cell therapy for patients with diabetes. By using a patient’s own cells for treatment, this innovative approach has the potential to transform diabetes care, offering a personalized and regenerative solution to one of the world’s most pervasive health challenges.
“We are honored to have supported GIOSTAR in bringing this groundbreaking trial to life,” said Dr. Mukesh Kumar, CEO of FDAMap. “This approval is a testament to their dedication to pioneering stem cell therapies and marks a major milestone in the fight against diabetes. We look forward to continuing our collaboration to advance this important work. Together, we are shaping the future of diabetes treatment and expanding the possibilities of stem cell therapeutics.”
About GIOSTAR
The Global Institute of Stem Cell Treatment and Research (GIOSTAR), based in San Diego, CA, is a world leader in stem cell research and development, committed to providing advanced therapies for degenerative and chronic diseases.
About FDAMap Clinical
FDAMap Clinical is a full-service CRO specializing in regulatory guidance, clinical trial management, and strategic planning for biopharma and regenerative medicine companies. Under the leadership of Dr. Mukesh Kumar, FDAMap Clinical has been instrumental in advancing innovative treatments like GIOSTAR’s cutting-edge stem cell therapies, guiding them through the complex FDA approval process. FDAMap Clinical is proud to play a key role in ensuring these transformative therapies reach patients in need.
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Media Contact:
Rachel Greiner
Director of Business Development
FDAMap Clinical
Phone: 1-877-566-4981
Email: rachelg@fdamap.com