MSC and HSC Coinfusion in Mismatched Minitransplants

  • End date
    Jul 25, 2023
  • participants needed
  • sponsor
    University of Liege
Updated on 25 January 2021
coronary artery disease
graft versus host disease
hematologic malignancy
blast crisis
mycophenolate mofetil
multiple myeloma
hodgkin's disease
myeloproliferative disorder
ejection fraction
myeloablative conditioning
transplant conditioning
serum bilirubin level


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.

Condition Bone marrow disorder, childhood ALL, Hodgkin's Disease, Multiple Myeloma, Lymphoma, Preleukemia, Acute myeloid leukemia, Lymphoproliferative Disorder, Lymphoma, Chronic Lymphocytic Leukemia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Chronic myeloid leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Myeloproliferative Neoplasms, Lymphocytic Leukemia, Acute, Lymphoproliferative disorders, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, non-hodgkin's lymphoma (nhl), leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, multiple myeloma (mm), myelodysplastic syndrome (mds), hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), chronic myelogenous leukemia
Treatment Mesenchymal stem cells, Isotonic solution, Isotonic solution
Clinical Study IdentifierNCT01045382
SponsorUniversity of Liege
Last Modified on25 January 2021


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Inclusion Criteria

Is your age less than or equal to 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Lymphocytic Leukemia or Bone marrow disorder or MYELODYSPLASTIC SYNDROME or Lymphocytic Leukemia, Chronic or Preleukemia or childhood ALL or L...?
Do you have any of these conditions: Lymphocytic Leukemia, Chronic or myelodysplastic syndromes or chronic myelogenous leukemia or Lymphoma or MYELODYSPLASTIC SYNDROME or non-hodgkin's ly...?
HIV positive
Terminal organ failure, except for renal failure (dialysis acceptable)
Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction <35%; uncontrolled arrhythmia; uncontrolled hypertension
Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen
Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease
Uncontrolled infection, arrhythmia or hypertension
Previous radiation therapy precluding the use of 2 Gy TBI
10 HLA-A, -B, -C, DRB1 and DQBI allele-matched donor fit to/willing to donate PBSC
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