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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004310-14-BE

Enrollment

120

Registered

2007-12-10

Start date

2007-12-13

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steroid resistant grade II to IV acute graft-versus-host disease (GVHD) or poor graft function after allogeneic hematopoietic cell transplantation MedDRA version: 21.1 Level: PT Classification code 10001756 Term: Allogenic bone marrow transplantation therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: PT Classification code 10045553 Term: Unrelated donor bone marrow transplantation therapy System Organ Class: 10042613 - Surgical and medical proced

Interventions

Product Name: Mesenchymal stem cells Product Code: MSC Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient eligibility criteria 1. Male or female of any age. 2. Previous allogeneic transplantation or autologous transplantation (for part 2 only) of HSC at any time before. 3. Informed consent given by donor or his/her guardian if of minor age. 4. Additional criteria for each part of the protocol: Part 1: MSC for steroid-refractory grade II-IV acute GVHD - Acute GVHD refractory to mPDN 2 mg/kg/day or equivalent Part 2: MSC for poor graft function (PGF) - Cytopenia in 2 or 3 lineages: - Cytopenia duration = 2 weeks beyond day 28 after autologous HCT, or day 42 Part 3: MSC + DLI for poor donor T-cell chimerism - Nonmyeloablative allogeneic transplantation. - Donor T-cell chimerism =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. HIV positive. 2. Active uncontrolled infection at time of scheduled MSC infusion. 3. Relapsing or progressing malignancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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, not eligible for, or not willing to participate to, the EBMT randomized protocol. Part 2: Poor graft function (PGF) Part 3: Low or falling donor T-cell chimerism after allogeneic HCT. ;Secondary Objective: 1. Toxicity of MSC infusions 2. Incidence of acute (Appendix A) and chronic GVHD (Appendix B). 3. Overall and progression-free survival. 4. Incidence of bacterial, fungal and viral infections. 5. Disease progression or relapse. 6. Evidence of epithelial cells of MSC donor origin (assessed by STR-PCR) in bone marrow (and organs affected by GVHD : for part 1 only) after MSC infusion.;Primary end point(s): To establish efficacy of infusions of MSC from related HLA-identical, HLA-haploidentical or mismatched unrelated donors: Part 1: MSC for steroid-refractory grade II-IV acute GVHD : efficacy on steroid-resistant grade II - IV acute GVHD. Part 2: MSC for poor graft function (PGF) : efficacy on PGF. Part 3: MSC + DLI for poor donor T-cell chimerism after allogeneic HCT : efficacy on prevention of graft rejection in patients with low or failing donor T-cell chimerism after allogeneic HCT.	—

Measure

Time frame

Main Objective: 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, not eligible for, or not willing to participate to, the EBMT randomized protocol. Part 2: Poor graft function (PGF) Part 3: Low or falling donor T-cell chimerism after allogeneic HCT. ;Secondary Objective: 1. Toxicity of MSC infusions 2. Incidence of acute (Appendix A) and chronic GVHD (Appendix B). 3. Overall and progression-free survival. 4. Incidence of bacterial, fungal and viral infections. 5. Disease progression or relapse. 6. Evidence of epithelial cells of MSC donor origin (assessed by STR-PCR) in bone marrow (and organs affected by GVHD : for part 1 only) after MSC infusion.;Primary end point(s): To establish efficacy of infusions of MSC from related HLA-identical, HLA-haploidentical or mismatched unrelated donors: Part 1: MSC for steroid-refractory grade II-IV acute GVHD : efficacy on steroid-resistant grade II - IV acute GVHD. Part 2: MSC for poor graft function (PGF) : efficacy on PGF. Part 3: MSC + DLI for poor donor T-cell chimerism after allogeneic HCT : efficacy on prevention of graft rejection in patients with low or failing donor T-cell chimerism after allogeneic HCT.

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Countries

Belgium

Contacts

Public Contact/

CHU-ULG

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026