Infusion of Mesenchymal Stem Cells as Treatment for Steroid-Resistant Grade II to IV Acute GVHD or Poor Graft Function: a Multicenter Phase II Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Graft-versus-host Disease
- Sponsor
- University of Liege
- Enrollment
- 100
- Locations
- 12
- Primary Endpoint
- Arm 1. Efficacy of MSC infusion as treatment for steroid-resistant grade II - IV acute GVHD.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
Part 1: complete recruitment Part 2: complete recruitment Part 3: recruiting
Investigators
Yves Beguin
Prof
University of Liege
Eligibility Criteria
Inclusion Criteria
- •Patient eligibility criteria
- •Male or female of any age.
- •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.
- •Any source of HSC (marrow, PBSC, cord blood) and any conditioning regimen.
- •Informed consent given by donor or his/her guardian if of minor age.
- •Additional criteria for each part of the protocol:
- •Part 1: MSC for steroid-refractory grade II-IV acute GVHD
- •Allogeneic transplantation.
- •Grade II-IV acute GVHD (see appendix A for acute GVHD grading) de novo or following DLI.
- •Acute GVHD refractory to mPDN 2 mg/kg/day or equivalent, defined as
Exclusion Criteria
- •Patient exclusion criteria
- •HIV positive.
- •Active uncontrolled infection at time of scheduled MSC infusion.
- •Relapsing or progressing malignancy.
- •MSC donor exclusion criteria
- •HIV positive
- •Known allergy to Lidocaine
- •If donor other than HSC donor : any risk factor for transmissible infectious diseases.
Outcomes
Primary Outcomes
Arm 1. Efficacy of MSC infusion as treatment for steroid-resistant grade II - IV acute GVHD.
Time Frame: 30 days
Arm 2. Efficacy of MSC infusion as treatment for poor graft function
Time Frame: 180 days
Arm 3. Efficacy of MSC infusion followed by donor lymphocyte infusion for preventing graft rejection in patients with low or failing donor T-cell chimerism after allogeneic HCT
Time Frame: 180 days
Secondary Outcomes
- Toxicity of MSC infusion(180 days)