U.S. Stem Cell, Inc.'s MARVEL Phase II/III Trial Receives Reactivation Status with the FDA
SUNRISE, FL / ACCESSWIRE / April 10, 2017 / U.S. Stem Cell, Inc. (USCC) (OTCQB: USRM), a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has received reactivation status of the MARVEL phase II/III trial with the Food and Drug Administration (FDA).
Following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Medicine Advanced Therapy (RMAT) Designation for the MyoCell product as part of the MARVEL trial. The trial had previously been placed on "Inactive Status" as patients were not actively being enrolled. A request was placed to the FDA to reactivate the protocol and consider the therapy for RMAT designation. We have recently heard from the FDA who has notified us that the protocol has been placed on "Reactivation Status" after reviewing details on the protocol and data collected on patients to date. The FDA has also notified us that they are still reviewing our submission for RMAT.
Thanks to the REGROW component of the Cures Act, the FDA will grant RMAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease. U.S. Stem Cell, Inc. believes that our MyoCell product meets these requirements as we have demonstrated clinical efficacy in both preclinical and clinical studies including our most recent MARVEL trial publication (review full publication here: https://www.ncbi.nlm.nih.gov/pubmed/21982657). Should RMAT designation be granted, this could expedite the approval process with the FDA.
More information on the FDA's new RMAT Designation may be found at: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
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