Cellect Biotechnology Ltd. has announced a collaboration with Washington University in St. Louis, Missouri, USA, in a U.S. Phase I/II study aimed at determining the safety and tolerability of using ApoGraft™ for bone marrow transplantations.
Founded in 2011, located in Tel Aviv, Isreal, Cellect Biotechnology has developed a breakthrough technology for the selection of stem cells from any given tissue to any application of those cells. The technology aims to improve a variety of cell-based therapies.
The Company’s technology is expected to provide research institutes, hospitals and pharma companies with the tools to rapidly produce stem cells in quantity and quality allowing cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company’s ongoing cancer clinical trial is treating patients undergoing bone marrow transplantations.
The collaboration is led by Dr. John DiPersio, Director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine and President of the American Society for Blood and Marrow Transplantation, and Dr. Mark Schroeder, an expert in bone marrow transplantation in the Division of Oncology at Washington University School of Medicine.
The open label clinical trial of twelve patients, expected to complete recruitment during the second quarter of 2019, is designed to evaluate the safety and tolerability of the ApoGraft™ process in patients with hematological malignancies who are undergoing an allogeneic hematopoietic stem cell transplantation (HSCT). The primary endpoint of the study is overall incidence, frequency and severity of adverse events potentially related to ApoGraft™ at 180 days from transplantation. Preliminary data reported in October by the Company indicated that:
- One-month assessment of half of the planned patients in the ApoGraft™ study show complete engraftment and no procedure-related adverse events.
- In the first three patients completing the full study, safety and tolerability were positive, with no related adverse events (the primary endpoint) and engraftment before 28 days post-transplant.
“This is a very significant development for Cellect and demonstrates that our leading technology is garnering attention from the most influential clinical institutions in the U.S.,” … “We have already reported positive preliminary results for a trial being conducted outside of the U.S., and I believe the collaborative efforts with a leading U.S.-based institution may advance and heighten awareness of our technology. We believe Cellect’s ApoGraft™ stem cell selection technology has the potential to improve the lives of millions of patients and be a game changer in bone marrow transplantation – the largest multi-billion-dollar segment of cell therapy in the U.S.” – Cellect CEO Dr. Shai Yarkoni