Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function
Trial Parameters
Brief Summary
The present project aims at investigating the role of MSC for the treatment of patients with Part 1: Steroid-refractory grade II-IV acute GVHD. Part 2: Poor graft function (PGF) Part 3: Low or falling donor T-cell chimerism after allogeneic HCT. This is a multicenter phase II study examining the feasibility and efficacy of this approach.
Eligibility Criteria
Inclusion Criteria: Patient eligibility criteria 1. Male or female of any age. 2. Previous allogeneic transplantation (related or unrelated donor, any degree of HLA matching) or autologous transplantation (for part 2 only) of HSC at any time before. 3. Any source of HSC (marrow, PBSC, cord blood) and any conditioning regimen. 4. Informed consent given by donor or his/her guardian if of minor age. 5. Additional criteria for each part of the protocol: Part 1: MSC for steroid-refractory grade II-IV acute GVHD 1. Allogeneic transplantation. 2. Grade II-IV acute GVHD (see appendix A for acute GVHD grading) de novo or following DLI. 3. Acute GVHD refractory to mPDN 2 mg/kg/day or equivalent, defined as * progression of GVHD on day 3 after initiation of steroids * no improvement of GVHD on day 7 after initiation of steroids * absence of complete resolution of acute GVHD on day 14 after initiation of steroids * relapse of acute GVHD during or after steroid taper. 4. Ongoing therapy with Ciclos