Medistem and Shanghai Jia Fu Medical Apparatus have announced the treatment of two patients with Endometrial Regenerative Cell (ERC) universal donor stem cell product as part of the critical limb ischemia study.
The ERC dosing procedure, which involves a series of intramuscular injections in the ischemic limb, was performed without any treatment-associated adverse events observed in either of the patients.
Thomas Ichim, Medistem CEO, said the ERC is amongst clinical grade stem cells in that the cell is derived from the endometrium (lining of the uterus).
"We believe the ERC plays a critical role in forming new blood vessels, which is supported by numerous experiments we have conducted," Ichim added.
"Since the biological role of the ERC is to produce new blood vessels, it is our desire to use these cells to produce new blood vessels in the legs of patients with critical limb ischemia."
The study, in collaboration with Shanghai Jia Fu Medical Apparatus, intends to expand Medistem's clinical cellular therapy portfolio that is based on DC-CIK, an autologous immunotherapy for cancer patients.
Medistem and Shanghai Jia Fu aim to develop the ERC product in China by performing a series of trials to obtain marketing approval.
Wei Zhang, Shanghai Jia Fu Medical Apparatus CEO, said due to the high incidence of diabetes in the Chinese population, critical limb ischemia is a significant cause of suffering in the country.
"We are optimistic that the lessons we have learned from successfully commercializing DC-CIK can be applied to the first universal donor stem cell that is extracted from the endometrium," Zhang added.