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

Phase 1

• Conditions: Steroid resistant grade II to IV acute graft-versus-host disease (GVHD) or poor graft function after allogeneic hematopoietic cell transplantation; MedDRA version: 21.1Level: PTClassification code 10001756Term: Allogenic bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: PTClassification code 10045553Term: Unrelated donor bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10018799Term: GVHDSystem Organ Class: 10021428 - Immune system disorders

• Registration Number: EUCTR2007-004310-14-BE
• Lead Sponsor: CHU-ULG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-10
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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 < 50% for at least 2 consecutive weeks beyond day 21 after HCT OR = 20% decrease in donor T-cell chimerism with the second value < 50%.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified