Patients with hematological malignancies not candidate for conventional allogeneic transplantation because of age or comorbidities. MedDRA version: 8.1 Level: LLT Classification code 10027703 Term: Mismatched donor bone marrow transplantation therapy
Conditions
Interventions
Product Name: Mesenchymal stem cells
Pharmaceutical Form: Intravenous infusion
Sponsors
CHU Sart-Tilman
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient 1. Hematological malignancies confirmed histologically and not rapidly progressing. 2. Theoretical indication for a standard allo-transplant, but not feasible because: Age > 55 yrs; Unacceptable end organ performance; Patient’s refusal. OR Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant. 3. Male or female; fertile female patients must use a reliable contraception method; 4 Age =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient 1 Any condition not fulfilling inclusion criteria; 2 HIV positive; 3 Terminal organ failure, except for renal failure (dialysis acceptable); 4 Uncontrolled infection, arrhythmia or hypertension; 5 Previous radiation therapy precluding the use of 2 Gy TBI; 6 HLA-identical donor. Donor 1 Any condition not fulfilling inclusion criteria; 2 HIV positive; 3 Unable to undergo leukapheresis because of poor vein access or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The present project aims at investigating the role of mesenchymal stem cells (MSC) for the prevention of graft rejection and graft-versus-host disease (GVHD) after allogeneic HCT with nonmyeloablative conditioning in patients receiving either HLA-mismatched peripheral blood stem cells (PBSC) from related or unrelated donors or banked cord blood. This is a non-randomized phase I-II study examining the feasibility and toxicity of this approach, and obtaining preliminary efficacy data for a later phase III study. Further, we will investigate, in vitro, the ability of MSC (the same as infused to the patient) to block/mitigate the induction of recipient skin explant GVHD by donor T-cells.;Secondary Objective: 1.To examine hematopoietic (whole blood and T cell chimerism) engraftment and to evaluate the incidence of graft rejection. 2.To evaluate the incidence of grade II-IV and III-IV acute graft-versus-host disease (GVHD). 3.To investigate the quality and timing of immunologic reconstitution. 4.To detect MSC of MSC donor origin in recipient marrow after HCT. 5.To assess the impact of MSC on skin GVHD in vitro in the skin explant model. ;Primary end point(s): To study the feasibility and safety (defined as a day-100 incidence of non-relapse mortality < 35%) of allogeneic hematopoietic transplantation following nonmyeloablative conditioning with co-infusion of mesenchymal stem cells and HLA-mismatched hematopoietic stem cells. | — |
Countries
Belgium
Outcome results
None listed