Cellect Biotechnology, a developer of innovative technology targeted towards making regenerative medicine using stem cells, recently received approval for their first ever U.S. clinical trial to assess the safety and tolerability of ApoGraft technology for haploidentical bone marrow transplants.
A haploidentical transplant is a type of allogeneic transplant that uses healthy, blood-forming cells from a half-matched donor to replace the unhealthy ones. Blood tests are done to find the human leukocyte antigen (HLA) type. HLA is a protein marker found on most cells in one’s body and helps identify a match for the transplant. The donor is typically a family member.
In 2017, FDA granted orphan drug designation for ApoGraft and the company is now working to get it designated for Regenerative Medicine Advanced Therapy (RMAT) under the Cures Act. The position would facilitate expedited development, review and approval for vital regenerative medicine therapies which indicated the potential to address a serious condition in preliminary clinical trials.
RMAT designated products may also become eligible for priority review and accelerated approval, which drastically reduce the time to market and the commercial value of the item.
Cellect Biotechnology recently received the approval for a clinical trial for ApoGraft. The company is partnering with Washington University School of Medicine in St. Louis to conduct a trial involving 18 subjects for the initial phase. Enrollment is expected to begin in the first half of 2020.
The approval of the protocol, constitutional for the trial to begin, came from the Washington University’s Institutional Review Board. Other successful milestones including the IND approval from the U.S. Food and Drug Administration (FDA), positive feedback from the institutional independent scientific committee and a complete technology transfer, followed the initial approval.
According to Dr. Shai Yarkoni, Chief Executive Officer, “With the succession of executed milestones, we are getting closer to achieving our primary objective of commencing our first clinical trial in the U.S. Our team, together with Washington University, is focused on this goal in the first half of 2020, aiming to achieve a level of success similar to our ongoing Phase 1/2 clinical trial being performed in Israel that shows initial promising results.”
The trial is lead by Zhifu Xiang, M.D, Ph.D, a principal investigator for the study. He is an Associate Professor in the Division of Oncology’s Bone Marrow Transplantation. Furthermore, John Dipersio M.D, Ph.D, is a co-Principal investigator and the chief of the Division of Oncology in the Department of Medicine at Washington University.
About the Institution Review Board (IRB)
IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities. It handles the responsibility of reviewing, before initiation, all research including human participants. It is mainly concerned with protecting the welfare rights and privacy of the human subjects, and has the authority to approve, disapprove, monitor and require changes in all research activities that fall in its jurisdiction.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (APOP) has developed a breakthrough technology aimed toward the improvement of stem cell based therapies by selecting stem cells from any given tissue. The main job of the company is to provide researchers etc. with the tools to rapidly isolate stem cells in different trials.