Clinical trial · Interventional
Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease
Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease After Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies and Myelodysplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was suspended pending renovation and reopening of the facility manufacturing the study product, and the study was ultimately terminated in February of 2026.
Summary
Brief summary (as posted)
The protocol is a phase I open label study evaluating the safety and feasibility of peri-transplant infusion of freshly expanded interferon gamma primed MSCs in adult and pediatric patients undergoing HCT for acute leukemia and myelodysplastic syndrome (MDS).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adult Population
- description
- Study participants aged 18 or older who are having an allogeneic blood and marrow transplant (BMT), to treat leukemia, lymphoma or other cancer of the blood will receive an infusion of mesenchymal stromal cells (MSCs).
- interventionNames
- Drug: Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells
- type
- EXPERIMENTAL
- label
- Pediatric Population
- description
- Study participants under 18 years of age who are having an allogeneic blood and marrow transplant (BMT), to treat leukemia, lymphoma or other cancer of the blood will receive an infusion of mesenchymal stromal cells (MSCs).
- interventionNames
- Drug: Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: * All transplant patients who undergo HCT with a myeloablative (MA) or Fludarabine/Melphalan (RIC) conditioning regimen and a HLA A- B- C- DR-matched unrelated donor as treatment for hematologic malignancy or MDS. * Age ≥ 1 year at the time that the informed consent document is signed. * Patients with acute leukemia must be in complete remission (defined as an M1 marrow -\<5% blasts- no evidence of extramedullary disease. Complete remissions without platelet recovery (CRp) will be considered remissions. * Planned GVHD prophylaxis with a calcineurin inhibitor and methotrexate per institutional standards. * Subject or parent/guardian must sign an informed consent document, and if appropriate, children must sign an assent document. Exclusion Criteria: * Patients who are to receive a non-myeloablative conditioning regimen. * Patients receiving another investigational drug for acute GVHD prevention during the conditioning regimen or a planned investigational drug for the first year after transplant (there are no restrictions on GVHD treatment). * Any medical or psychological condition or situation deemed by the Investigators to put the patient at increased risk of complications or non-compliance. * Patient with a secondary malignancy who would be otherwise eligible for study, but for whom remission from the primary disease cannot be conclusively confirmed or for whom the chance of relapse of the primary disease is significant. * Pregnancy (positive serum b-HCG) or breastfeeding. * Estimated glomerular filtration rate (GFR) of \< 50 mL/min/1.73m2. * Cardiac ejection fraction \< 50 (using M-Mode if assessment is done by Echocardiogram) * T bilirubin \> 2 × upper limit of normal or alanine aminotransferase (ALT) \> 4 × upper limit of normal or aspartate aminotransferase (AST) \> 4 x upper limit of normal unresolved veno-occlusive disease * Pulmonary disease with forced vital capacity (FVC), forced expiratory volume (FEV1) or diffusing capacity for carbon monoxide (DLCO) parameters \<45% predicted (corrected for hemoglobin) or requiring supplemental oxygen. Children who are developmentally unable to perform pulmonary function testing will be assessed solely on their need for supplemental oxygen. * Karnofsky performance score or Lansky Play-Performance Scale score \<80 * Human leukocyte antigen (HLA) antibody screen positive for HLA antibodies specific against the MSC products.
References
Publications (0)
Data not yet available