Human Life CORD Co., Ltd. (President and CEO: Masamitsu Harada, Location: Chuo-ku, Tokyo), which is aiming for the world’s pioneering product commercialization in the mesenchymal stromal cells extracted from the umbilical cord, has begun infusion therapy with HLC-001 to the first patient in this disease. The Safety Assessment Committee, which was held on November 17, 2022, concluded that there were no problems with safety and that it was possible to register the second patient and later with no problems with safety. The study was conducted in a Phase II study subject non-infectious complication diseases after hemopoietic stem cell transplantation.
This study aims to reduce overactive immunity and excessive inflammation through umbilical cord-derived mesenchymal stromal cell transfusion therapy developed by us. This study aims to restore respiratory function, which is unlikely to lead to mechanical ventilation, and to improve the survivability of patients with non-infectious pulmonary complications (IPS) who became steroid-resistant after hematopoietic stem cell transplantation.
No useful treatment for this disease has been established not only in Japan but also in the world. We will continue to carefully evaluate, for example, the effectiveness of HLC-001 (umbilical cord-derived mesenchymal stromal cells) as a key component in establishing a global lead.
[Comments from Masamitsu Harada, our President and CEO]
Human Life CORD selects diseases with high global unmet medical needs (unmet medical needs) that can take advantage of the characteristics of umbilical cord-derived mesenchymal stromal cells. The disease targeted in this study, non-infectious complication disease after hematopoietic stem cell transplantation, has a high mortality rate due to the lack of effective treatment at present, and is a rare and intractable disease with an extremely small number of patients: approximately 300 patients in Japan and 3,500 patients worldwide (*). As a result, it is expected that many difficulties will be encountered. However, for patients and their families who are waiting, so that the aspirations of all those involved in the trial will lead to the hope of life for as many patients as possible. Although no one else in the world has achieved this, we will continue to relentlessly take on the challenges to improve the survival rate of this disease, and we will accumulate evidence that can be disseminated not only in Japan but also worldwide.
※The number of patients was estimated from the material of the 40th Hematopoietic Stem Cell Transplantation Committee of the Committee on Disease Measures of the Health Sciences Council, MHLW.