Clinical Trial recruitment success
20 July 2017
The UHBristol Haematology and Oncology Centre Clinical Trials Unit are the first to recruit globally for A Study of CYP-001 for the Treatment of Steroid-Resistant Acute Graft Versus Host Disease.
Allogeneic stem cell transplantation is a potentially curative treatment for patients with cancer and bone marrow failure although is associated with significant serious side effects. Acute graft versus host disease (aGvHD) is the result of the donor immune system, mediated by lymphocytes attacking the recipient tissues, and is one of the most serious complications of allogeneic transplantation. This typically occurs within the first 3 months following transplant and affects up to two thirds of transplant recipients. Significant aGvHD is treated with corticosteroids although up to half of patients require subsequent lines therapy. Currently available treatments for steroid refractory aGvHD are often ineffective and there is no standard of care and the mortality for patients with resistant aGvHD is high. Mesenchymal Stem Cells (MSC) are able to inhibit a range of inflammatory cells including lymphocytes, natural killer cells and dendritic cells, on which basis they have been investigated as a possible treatment for aGvHD. Results of previous studies using MSC in aGvHD have been mixed. The study will assess the safety, tolerability and efficacy of two infusions of MSC (CYP 001) produced using a novel technology to facilitate cell expansion without loss of efficacy.
The Bristol PI is Dr James Griffin.