MedTrace Logo

Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease

NCT04328714 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-02-13

No results posted yet for this study

Summary

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

Interventions

DRUG

Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells

To determine the maximal dose, initially adult subjects will receive a single infusion of third party, freshly ex vivo expanded, IFNγ-primed MSCs at a dose of 2 x 106 cells/kg of ideal body weight on Day +1 (the day after infusion of the hematopoietic cell graft). The dose will be escalated to 5 x 106 and then 10 x 106 cells/kg. In absence of any dose limiting toxicity, 10 x 106 cells/kg will be accepted as the maximal dose. Subsequent participants in the adult and pediatric cohorts will receive the maximal dose as determined by the initial adult participants. Participants will receive the infusion in an inpatient setting. MSCs will be intravenously infused through a central line or a large bore peripheral IV using standard blood product tubing within 4 hours of release. The product will be infused by IV push or syringe pump over approximately 30-60 minutes or to gravity depending on product volume.

Sponsors & Collaborators

  • Ossium Health, Inc.

    collaborator INDUSTRY

  • Edwin Horwitz

    lead OTHER

Principal Investigators

  • Edwin Horwitz, MD, PhD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-02
Primary Completion
2022-07-20
Completion
2022-07-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04328714 on ClinicalTrials.gov