UnknownPhase 2

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

Belgium, Netherlands100 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

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Sex

ALL

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

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