Date: 2014-10-27
Type of information: Initiation of the trial
phase: preclinical
Announcement: initiation of the trial
Company: Pluristem Therapeutics (Israel) Case Western Reserve University (USA - OH)
Product: PLX-RAD cells
Action mechanism:
Disease: human umbilical cord blood transplantation
Therapeutic area: Transplantation - Regenerative medicine
Country: USA
Trial
details: The primary objective of the study at Case Western Reserve is to determine the benefits of administering PLX-RAD cells at the time of transplantation of human hematopoietic CD34+ cells collected from umbilical cord blood. Scientists will compare the success rates of transplant engraftment in the control arm versus those treated with PLX-RAD cells. The secondary objective is to determine if there are any histologic changes in the liver, lung, spleen and intestine in the control versus treated groups. The preclinical study will be conducted in an immunodeficient mouse model that has undergone non-lethal radiation to destroy its own bone marrow cells. There will be three arms in the study: 1) IV (intravenous) injection of human Hematopoietic Cells (hHC) alone for the control; 2) IV injection of hHC plus IV injection of 1 million PLX-RAD cells; 3) IV injection of hHC plus intramuscular (IM) injection of 1 million PLX RAD cells. At 8 weeks bone marrow of the mice will be analyzed.
Latest
news: * On October 27, 2014, Pluristem Therapeutics, an Israelian developer of placenta-derived cell therapy products, announced that researchers at Case Western Reserve University will conduct a preclinical study of its PLacental eXpanded (PLX)-RAD cells. The study will evaluate whether PLX-RAD cells increase the success rate of human umbilical cord blood transplantation.
Umbilical cord blood cells are transplanted to replace a patient’s unhealthy bone marrow cells. When successful, a transplant can treat bone marrow failure, which can result from immune system disorders, genetic diseases, and leukemia treatment. When cord blood cells are administered to a patient, they travel to the bone marrow and produce healthy white and red blood cells and platelets after the patient’s own abnormal cells have been eliminated. Sometimes, however, the cord blood cells fail to take hold and the transplant fails. The study at Case Western Reserve will research the feasibility of using PLX-RAD cells to help the cord blood to engraft more effectively, resulting in higher rates of successful transplantation and treatment.
“Case Western Reserve is one of the top research institutes in the U.S. and we are delighted to work with them. Pluristem will provide the PLX-RAD cells and the university’s researchers will conduct the study,” stated Pluristem’s Chairman and CEO Zami Aberman.
“If animal data show that PLX-RAD cells increase the success rate of umbilical cord blood transplants, this would motivate us to apply to conduct human clinical trials for bone marrow reconstitution following radiation in a number of life-threatening diseases including leukemia, where development of new, healthy bone marrow is the only available cure,” Aberman concluded.
PLX-RAD cells are also being studied by the U.S. National Institutes of Health (NIH) for the treatment of acute radiation syndrome (ARS), which involves bone marrow failure after exposure to high levels of radiation, as can happen after a nuclear catastrophe.
