Trials / Terminated
TerminatedNCT01045382
MSC and HSC Coinfusion in Mismatched Minitransplants
Co-transplantation of Mesenchymal Stem Cells and HLA-mismatched Allogeneic Hematopoietic Cells After Nonmyeloablative Conditioning: a Phase II Randomized Double-blind Study
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- University of Liege · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
Summary
The present project aims at evaluating the capacity of MSC to improve one-year overall survival of patients transplanted with HLA-mismatched PBSC from related or unrelated donors after non-myeloablative conditioning. Co-infusion of MSC has been shown to facilitate engraftment of hematopoietic stem cell (HSC) in an immunodeficient mouse model. In addition, it has been shown that infusion of third party MSC in HSC transplantation could be successfully used as treatment for grade II-IV steroid-refractory acute graft versus host disease. One hundred and twenty patients with HLA-mismatched donors will be included over 6 years at multiple centers across Belgium through the transplant committee of the Belgian Hematological Society. The conditioning regimen will consist of fludarabine and 2 Gy TBI, followed by the infusion of donor HSC. Patients will be randomized 1/1 in double-blind fashion to receive or not MSC (1.5-.3.0 x106/kg) from third-party (either haploidentical family members or unrelated volunteer) donors on day 0. Postgrafting immunosuppression will combine tacrolimus and MMF. Except for the collection, expansion and infusion of MSC, the clinical management of the patient will not differ from that of routine NM-HCT.
Conditions
- Leukemia, Myeloid, Acute
- Leukemia, Lymphoblastic, Acute
- Leukemia, Myelocytic, Chronic
- Myeloproliferative Disorders
- Myelodysplastic Syndromes
- Multiple Myeloma
- Leukemia, Lymphocytic, Chronic
- Hodgkin's Disease
- Lymphoma, Non-Hodgkin
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Mesenchymal stem cells | Mesenchymal stem cell injection |
| OTHER | Isotonic solution | Isotonic solution injection |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2010-01-11
- Last updated
- 2021-09-08
Locations
10 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01045382. Inclusion in this directory is not an endorsement.