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 STROMAL CELLS FOR GVHD PREVENTION

What's the purpose of this trial?

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).

This trial has suspended patient recruitment.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Phase 1

Enrollment: 45 patients (estimated)

View More

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


Winship Cancer Institute Emory University

Atlanta, GA

Temporarily Suspended

Children's Healthcare of Atlanta Egleston Hospital

Atlanta, GA

Temporarily Suspended
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message