← Back to Search

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

Phase 1

Waitlist Available

Led By Muna Qayed, MD

Research Sponsored by Edwin Horwitz

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to year 2

Awards & highlights

Study Summary

This trial is testing whether it is safe to give patients an infusion of freshly expanded interferon gamma-primed MSCs around the time of their HCT for leukemia or MDS.

Eligible Conditions

Acute Leukemia
Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximal Tolerated Dose

Number of adverse events attributed to the investigational product

Number of successful preparations and deliveries of investigational product

Secondary outcome measures

Change in Acute graft-versus-host disease (aGvHD) Incidence

Change in Chronic graft-versus-host disease (cGvHD) Incidence

Disease-free survival (DFS)

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pediatric PopulationExperimental Treatment1 Intervention

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).

Group II: Adult PopulationExperimental Treatment1 Intervention

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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Edwin HorwitzLead Sponsor

Ossium Health, Inc.Industry Sponsor

9 Previous Clinical Trials

103 Total Patients Enrolled

Muna Qayed, MDPrincipal InvestigatorEmory University

2 Previous Clinical Trials

29 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the core objectives of this research project?

"The primary result of this clinical investigation, which is assessed on Day 1 post-infusion, is the Maximum Tolerated Dose. Secondary objectives comprise Relapse (as evidenced by either morphological or cytogenetic markers for AML/ALL/MDS including MRD), Platelet Engraftment (when 3 consecutive platelet counts exceed 20k and 50K without transfusions in 7 days prior) as well as a Change in Acute Graft-versus-Host Disease Incidence based upon Revised Glucksberg criteria."

Answered by AI

Has this specific clinical trial been conducted previously?

"Currently, there are 37 clinical trials underway for Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells in 19 nations and 23 urban centres. This novel medical intervention first entered the scene back in 2011, when BioMérieux's Phase 3 trial was conducted with 20 patients. Since then, an additional 45 studies have been undertaken."

Answered by AI

How many individuals are enrolled in this experiment?

"Affirmative. Information found on clinicaltrials.gov confirms that the research is actively recruiting, having been first published December 2nd 2021 and last modified July 15th 2022. 45 volunteers must be recruited from 3 distinct medical centres."

Answered by AI

Are there any openings for volunteers to join this experiment?

"It appears that this medical trial is still in the process of scouting for participants. The original posting date was 2nd December 2021, with updates having been made as recently as 15th July 2022 (per clinicaltrials.gov)."

Answered by AI

Has the FDA sanctioned Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells as a viable therapy?

"Due to the limited safety and efficacy data, our team at Power rated Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells with a score of 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Edwin Horwitz 2021. "Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04328714.