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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

Must not have

Progressive underlying malignant disease or post-transplant lymphoproliferative disease

Active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I have received a stem cell transplant from a donor.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is getting worse or I have a disease after a transplant.

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I currently have cancer.

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I cannot undergo photopheresis due to health reasons.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of participants with response to therapy

Secondary study objectives

Average time to relapse

CD4:CD8 ratio

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

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met