Human Life CORD Japan Inc. (President and CEO: Masamitsu Harata, Headquarters: Tokyo, Japan; “the Company”), which aims to pioneer the practical application of cell therapy using umbilical cord-derived mesenchymal stromal cells (“UC-MSCs”), announces the update on a clinical Phase II trial in Japan of HLC-001, the Company’s clinically investigational product using UC-MSCs, for the treatment of non-infectious pulmonary complications following hematopoietic stem cell transplantation (“NIPCs”).
It is reported that NIPCs can occur in approximately 30% of patients undergoing hematopoietic stem cell transplantation and that the response to the standard therapy using steroids is limited. If the patient is resistant to steroid treatment (no improvement in the condition even with appropriate steroid treatment), it will progress irreversibly, and fall into a life-threatening condition with a high mortality rate for which no established treatment currently exists. Lung transplantation can be considered one of the treatment options, but its applicability is limited. Therefore, practical application of new treatment option for the patients is urgently needed in the current medical situation.
This Phase II trial was conducted to explore the efficacy and safety of HLC-001 for NIPCs with steroid resistance. HLC-001 met the pre-specified primary endpoint for its efficacy with the results concerning the survival rate of the subjects enrolled in this trial. In addition, no significant safety concerns were observed with HLC-001.
Based on the results of this trial, the Company will continue to consult with PMDA (Japan’s Pharmaceuticals and Medical Devices Agency) regarding the future directions.