StemMedical A/S today announced that the Danish Medicines Agency (DMA) has approved the Part 1 Clinical Trial Application (CTA) under the new EU Clinical Trial Regulation (CTR) for a phase 1 safety trial investigating STEM-OA, a cell-based product containing ex-vivo expanded adipose-derived mesenchymal stem/stromal cells (MSC(AT)s)to be reconstituted in the patient’s own fat, for the treatment of knee osteoarthritis (OA).
“We are pleased with the DMA part 1-approval for our phase 1 study with STEM-OA, as it enables us to accelerate our cell-based drug candidate and develop a therapy that can profoundly impact the lives of patients with knee osteoarthritis” said Michiel van Leeuwen, Chief Medical Officer at StemMedical®. “Knee osteoarthritis has a highunmet need with more than 300 million patients worldwide, and our platform is uniquely suited to develop a competitive product.”
“This approval is an important achievement as it supports our mission to fully utilize StemMedical’s unique MSC technology platform and develop Advanced Therapy Medicinal Product (ATMP) medicines for chronic diseases” said Klaus Langhoff-Roos, chief executive officer at StemMedical.
Read MedWatch Article here: https://medwatch.dk/Medicinal___Biotek/article16563459.ece
STEM-OA is the first pipeline asset within the therapeutic business line of StemMedical. It consists of ex-vivo expanded MSC(AT)s for both autologous and allogeneic administration (autoSTEM-OA and alloSTEM-OA) for the treatment of mild to moderate knee osteoarthritis. The ex-vivo expanded MSC(AT)s are reconstituted in freshly harvested autologous fat before intra-articular injection into the knee.
Stemform® is an approved cell-based natural filler product consisting of ex-vivo expanded autologous MSC(AT)s. Stemform® is reconstituted with freshly harvested autologous fat before it’s applied through a fat grafting procedure of the breast. Stemform® is currently available for breast augmentation (Stemform® BA) or following artificial implant removal (Stemform® AIR)
StemMedical A/S is a private Denmark-based cell therapy biotech dedicated to drive change to create a new paradigm for stem cell regenerative therapies. StemMedical is meeting this ambition through its two focus areas lines: FemHealth and Therapeutics. In FemHealth we focus on plastic and reconstructive surgery, and our product Stemform® is commercially launched in Denmark. In Therapeutics, we are initially focusing on osteoarthritis of the knee through our Stem-OA pipeline asset.
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