← Back to Search

Mesenchymal Stromal Cell Therapy

ECP + MSC Infusion for Graft-versus-Host Disease

Phase 2

Waitlist Available

Led By Molly Gallogly, MD, PhD

Research Sponsored by Molly Gallogly

Eligibility Criteria Checklist

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

Must have

Participants who underwent an allogeneic hematopoietic stem cell transplantation from any donor source

Eastern Cooperative Oncology Group Performance status ≤ 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing if two treatments can be given together safely to help improve symptoms of GvHD.

Who is the study for?

This trial is for people with severe Graft versus Host Disease (GvHD) after a stem cell transplant. They must have specific stages of skin, liver, or gastrointestinal involvement and may be those not responding to standard steroid treatments. Participants need stable vital signs, adequate blood counts, and suitable veins for the treatment process.Check my eligibility

What is being tested?

The study tests if combining two therapies—extracorporeal photopheresis (ECP) and Mesenchymal Stromal Cell (MSC) infusion—is safe and effective in treating symptoms of GvHD. ECP involves treating the blood with light after adding a drug that makes affected cells more sensitive to light; MSCs are infused to potentially repair tissue damage.See study design

What are the potential side effects?

Potential side effects include reactions related to the infusion such as fever or chills, increased risk of infection from immune suppression by MSCs, photosensitivity due to ECP treatment drugs, and possible discomfort from vascular access used during ECP.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have received a stem cell transplant from a donor.

Select...

I can at least take care of myself, but I am unable to do any work activities.

Select...

I have high-risk acute GVHD or steroid-refractory acute GVHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percent of participants with response to therapy

Secondary outcome measures

Average time to relapse

CD4:CD8 ratio

Change in FACT-BMT (Functional Assesment of Cancer Therapy-Bone Marrow Transplant) survey score

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: MSCs + ECPExperimental Treatment2 Interventions

The treatment period consists of a single, 28-day cycle. Participants will be treated with ECP 2 to 3 times per week per the discretion of the treating physician. Participants will receive IV infusions of MSCs on days 1 (+ 2 days) and 8 (+/- 2 days). A third dose may be given on day 15 (+/- 2 days) if the principal investigator (PI) and treating physician determine the MSC infusions have benefited the participant. Participants will be followed for up to 1 year for assessment of endpoints.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Extracorporeal photopheresis (ECP)

2002

Completed Phase 3

~350

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Molly GalloglyLead Sponsor

1 Previous Clinical Trials

65 Total Patients Enrolled

Molly Gallogly, MD, PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

2 Previous Clinical Trials

39 Total Patients Enrolled

Media Library

Allogeneic Mesenchymal Stromal Cells (MSCs) (Mesenchymal Stromal Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05333029 — Phase 2

Graft-versus-Host Disease Research Study Groups: MSCs + ECP

Graft-versus-Host Disease Clinical Trial 2023: Allogeneic Mesenchymal Stromal Cells (MSCs) Highlights & Side Effects. Trial Name: NCT05333029 — Phase 2

Allogeneic Mesenchymal Stromal Cells (MSCs) (Mesenchymal Stromal Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05333029 — Phase 2

Frequently Asked Questions

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

Has the Food and Drug Administration sanctioned Allogeneic mesenchymal stromal cells (MSCs) for use?

"As this is a Phase 2 trial, meaning efficacy has yet to be tested and there is some data supporting safety, Allogeneic mesenchymal stromal cells (MSCs) were assigned an approximate score of 2."

Answered by AI

Are there vacancies for patients to join this experiment?

"Clinicaltrials.gov reveals that this study, which was first posted on April 1st 2023 is not currently recruiting patients. However, there are 169 other trials actively looking for individuals wishing to participate in medical research."

Answered by AI

Does this experiment accept participants who are over 45 years of age?

"In order to qualify for this trial, applicants must have an age between 18 and 75. There are 63 trials available specifically targeting minors while 145 studies involve participants over the retirement age."

Answered by AI

Would I qualify for the requirements of this experimental research?

"Enrollees in this trial must be between 18 and 75 years old, have skin stage 3 or lower GI/Liver GVHD ≥ 2; Skin Stage 4, Lower GI stage ≥3, Liver stage ≥3; Hyper-acute GVHD as specified by aGVHD occurring within the first two weeks of transplantation. Furthermore they should display Grade 2 to 4 aGVHD with high risk disease identified through Viracor Eurofins Symptomatic Onset or Post-Treatment Algorithm. Additionally progression of aGVHD after treatment initiation (2 mg/kg/day methylprednisolone) for"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extracorporeal Photopheresis and Mesenchymal Stem Cell Infusion for GVHD

Molly Gallogly 2024. "Extracorporeal Photopheresis and Mesenchymal Stem Cell Infusion for GVHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05333029.

All > Gvhd