First Group of Patients in Clinical Trial With Cellect’s ApoGraft Stem Cell Transplant Follow up Results. 100% Acceptance and Zero Related Adverse Events
Dr. Shai Yarkoni, Cellect CEO commented: “These interim results further support that we are closer than ever to a world where stem cells are used to replace sick organs and damaged tissues.”
Cellect’s technology, ApoGraft™, aims to become a game changer in stem cell use for regenerative medicine
Jan 4, 2018 /PRNewswire/ — Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of a novel stem cell selection technology, announced that it has successfully completed transplantation of the first group of three patients using Cellect’s ApoGraft™ technology in the Company’s Phase I/II clinical trial and that after one month follow-up, all three patients have demonstrated complete acceptance of the stem cell transplant with no adverse events related to the study treatment, as determined by the clinical investigator, and no reported serious adverse events or suspected unexpected serious adverse reactions.
The Phase I/II, dose escalating, 4-cohort, open label clinical trial of up to twelve patients is designed to evaluate the safety, tolerability and efficacy of functionally selected donor derived mobilized peripheral blood cells that underwent the Company’s ApoGraft™ process and were transplanted into patients with hematological malignancies in an allogeneic hematopoietic stem cell transplantation. The primary endpoint of the study is overall incidence, frequency and severity of adverse events potentially related to ApoGraft™ at 180 days from transplantation. The Company plans on recruiting a further three patients for the second cohort of patients following review of the independent data and safety monitoring board.
The Company believes that these interim results of ApoGraft present the first signs of a breakthrough in stem cell transplantation. The product is transplantable within less than 12 hours from donation through a simple process performed on the bedside after selective physiological elimination of immune reaction-causing cells. The ApoGraft transplantation is intended to result in complete recovery of the patient’s immune system with no related safety concerns in contrast to the significant morbidity or even death causing standard medical procedure.
Dr. Shai Yarkoni, Cellect’s CEO said, “Our ApoGraft™ technology shows consistently successful results in the use of stem cell transplants for treating patients suffering from life-threatening conditions. We see our position strengthened with each patient treated. We aim for stem cell based regenerative medicine to become a safe and affordable treatment for most of mankind’s diseases.”
Stem cells are the building blocks and raw material of 21st century regenerative medicine enabling a world where damaged tissues and organs may be replaced and regenerated rather than fixed with drugs, radiation and surgery. However, up to 50 percent of stem cell transplant procedures, such as bone marrow transplants and others, result in life-threatening rejection disease and other immune responses such as Graft-versus-Host-Disease (GvHD). Cellect’s ApoGraft™ technology aims to turn stem cell transplantations into a simple and safe, yet cost effective procedure by reducing the associated severe side effects, such as rejection and many other risks.