RecruitingPhase 2

Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function

Belgium100 participantsStarted 2008-01

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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:
✓. 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

✕. HIV positive.
✕. Active uncontrolled infection at time of scheduled MSC infusion.
✕. Relapsing or progressing malignancy.
✕. HIV positive
✕. Known allergy to Lidocaine
✕. If donor other than HSC donor : any risk factor for transmissible infectious diseases.

What they're measuring

Arm 1. Efficacy of MSC infusion as treatment for steroid-resistant grade II - IV acute GVHD.

Timeframe: 30 days

Arm 2. Efficacy of MSC infusion as treatment for poor graft function

Timeframe: 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

Timeframe: 180 days

Trial details

NCT IDNCT00603330

SponsorUniversity of Liege

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08

Contact for this trial

Yves Beguin, MD, PhD

32-4-366 72 01 yves.beguin@chu.ulg.ac.be

View on ClinicalTrials.gov More Graft-versus-host Disease trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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:
✓. 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

✕. HIV positive.
✕. Active uncontrolled infection at time of scheduled MSC infusion.
✕. Relapsing or progressing malignancy.
✕. HIV positive
✕. Known allergy to Lidocaine
✕. If donor other than HSC donor : any risk factor for transmissible infectious diseases.

What they're measuring

Arm 1. Efficacy of MSC infusion as treatment for steroid-resistant grade II - IV acute GVHD.

Timeframe: 30 days

Arm 2. Efficacy of MSC infusion as treatment for poor graft function

Timeframe: 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

Timeframe: 180 days