Clinical trial · Interventional
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning: a Pilot Study
NCT00504803CI-TRIAL-00005443completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mesenchymal stem cell infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- MSC co-infusion with either HLA-mismatched PBSC or cord blood
- interventionNames
- Procedure: Mesenchymal stem cell infusion
Primary outcomes (1)
- measure
- Day-100 incidence of non-relapse mortality
- timeFrame
- 100 days
Secondary outcomes (1)
- measure
- 1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution
- timeFrame
- 365 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
V.1. Patients V.1.1. Diseases Hematological malignancies confirmed histologically and not rapidly progressing: * AML in CR; * ALL in CR; * CML unresponsive/intolerant to Imatinib but not in blast crisis; * Other myeloproliferative disorders not in blast crisis and not with extensive myelofibrosis; * MDS with \< 5% blasts; * Multiple myeloma; * CLL; * Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease); * Hodgkin's disease. V.1.2. Clinical situations * Theoretical indication for a standard allo-transplant, but not feasible because: * Age \> 55 yrs; * Unacceptable end organ performance; * Patient's refusal. * Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant. V.1.3. Other inclusion criteria * Male or female; fertile female patients must use a reliable contraception method; * Age \< 75 yrs. * Informed consent given by patient or his/her guardian if of minor age. V.1.4. Exclusion criteria * Any condition not fulfilling inclusion criteria; * HIV positive; * Terminal organ failure, except for renal failure (dialysis acceptable); * Uncontrolled infection, arrhythmia or hypertension; * Previous radiation therapy precluding the use of 2 Gy TBI; * HLA-identical donor. V.2. PBSC donors V.2.1. Inclusion criteria * Related to the recipient (sibling, parent or child) or unrelated; * Male or female; * Weight \> 15 Kg (because of leukapheresis); * Fulfills generally accepted criteria for allogeneic PBSC donation; * Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures. V.2.2. Exclusion criteria * Any condition not fulfilling inclusion criteria; * HIV positive; * Unable to undergo leukapheresis because of poor vein access or other reasons. V.2.3. HLA matching Related or unrelated donors who have 1-2 HLA mismatches, as either : * One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1 * One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1 * Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1 * One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1. * One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1 V.3. Cord blood unit Banked cord blood units will be used if they fulfill the following criteria: * No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic mismatch at HLA-DRB1) * \> 2.5 x 107 TNC/kg * Standard validation by FACT/Netcord criteria.
References
Publications (1)
- DERIVEDBaron F, Lechanteur C, Willems E, Bruck F, Baudoux E, Seidel L, Vanbellinghen JF, Hafraoui K, Lejeune M, Gothot A, Fillet G, Beguin Y. Cotransplantation of mesenchymal stem cells might prevent death from graft-versus-host disease (GVHD) without abrogating graft-versus-tumor effects after HLA-mismatched allogeneic transplantation following nonmyeloablative conditioning. Biol Blood Marrow Transplant. 2010 Jun;16(6):838-47. doi: 10.1016/j.bbmt.2010.01.011. Epub 2010 Jan 28. PMID 20109568