The German Ministry of Health has approved Israeli Pluristem’s drug, from women’s placenta cells after cesarean section. Placenta have been shown to induce a self-healing process.
Israeli Biotechnology Company Pluristem Therapeutics is expanding to Europe in search for a cure for COVID-19.
The German Ministry of Health Paul Ehrlich Institute (PEI) has approved the protocol for a Phase 2 clinical trial for the treatment of coronavirus heart disease patients with a complication of acute respiratory distress syndrome (ARDS).
The study will examine the efficacy and safety of PLX cell therapy and will include 40 patients. This is in parallel with the Phase 2 clinical trial in COVID-19 patients that has already begun in the US and is expected to include 140 patients.
According to the company announcement, the main parameter for evaluating the effectiveness of treatment is the number of days without artificial respiration during the first 28 days of the study.
Folow up reviews to examine patients’ safety and survival will be held on the 60th day of the study as well as on the 26th and 52nd weeks.
Pluristem’s drug is produced from a cell that originates in the placenta of women after childbirth by caesarean section, and is given by injection into a muscle, without any need for genetic matching between the donor and the patient.
Findings from previous preclinical studies in PLX cells have shown efficacy in the treatment of models in hypertension and pulmonary fibrosis, as well as in models of acute renal injury and gastrointestinal injury that are possible complications of cobid-19 infection.
The cell growth process is done in a Pluristem cell production plant which is the only one of its kind in the world and with a unique technology registered as a patent and developed by the company.
Pluristem CEO and President Yaki Yanai said: “Based on our discussions with the PEI, this will be a standalone study, with the active arm compared to the current standard of care. Pluristem is conducting several advanced clinical development programs in Europe.”
Pluristem placenta cells are currently at the center of Phase 3 clinical trials in two other medical conditions – muscle injury after a hip fracture and ischemia in the lower extremities. The cells have been shown to stimulate the body’s recovery mechanism by secreting proteins in response to signals from the patient’s body. The proteins initiate a process of self-healing and improve the patient’s condition.