The clinical trial in accordance with the German Medicines Act is entitled: "Phase I/IIa study to test the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint".
In close cooperation with eight renowned clinics as test centres and the partner institutions Fraunhofer Institute for Cell Therapy and Immunology (IZI), which is responsible for producing the clinical test samples under GMP, the Polski Bank Komórek Macierzystych (PBKM) and the Coordination Centre for Clinical Studies (KKS) Dresden of the TU Dresden, BIONCaRT will conduct the study over the coming months. Prof. Jörg Lützner, MD, University Centre for Orthopaedics, Trauma & Plastic Surgery, Carl Gustav Carus University Hospital, TU Dresden will lead the study
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"The approval of this study is an important milestone for BIONCaRT and our partners. It brings us closer to our goal of providing access to cell-based regenerative therapies for all patients of all ages," says Dr André Gerth, CEO of BIONCaRT. "We would like to thank the regulatory authority for their trust and our partners for their committed and competent cooperation."
This study is another important step for BIONCaRT on the path to clinical translation of innovative cell-based therapies. The results of the Phase I/IIa study will be decisive for the further development programme and the approval process.
"As a local venture capital investor, we are delighted to be able to support BIONCaRT, a Central German life science company, on its path to clinical translation. The study that has now started is an important step for the development of novel, cell-based therapies and at the same time strengthens Saxony and Thuringia as a biotechnology location." - Katja Butzmann, Managing Director, bm|t Beteiligungsmanagement Thüringen GmbH & Oliver Latz, Senior Investment Manager, TGFS Technologiegründerfonds Sachsen.
About BIONCaRT
As a research-based pharmaceutical company, BIONCaRT focuses on the development of cell-therapeutic drugs for clinical use in humans, particularly for the treatment of orthopaedic diseases. The focus is primarily on allogeneic therapy concepts. The company's main focus is on the development, authorisation and manufacture of stem cell-based medicinal products.
Press contact:
Dr Heike Opitz
Manager Business Development
BIONCaRT GmbH
+49 176 72515224
heike.opitz@bioncart
https://bioncart.com
