ECP + MSC Infusion for Graft-versus-Host Disease

Palo Alto (17 mi)

Overseen byMolly Gallogly, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Molly Gallogly

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to see if two treatments (extracorporeal photopheresis and Mesenchymal Stromal Cell (MSC) infusion, can be given safely together, and if they improve the symptoms of a Graft versus Host Disease (GvHD), a complication that can occur in people who undergo stem cell transplant.

Eligibility Criteria

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.

Inclusion Criteria

I have received a stem cell transplant from a donor.

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

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

Exclusion Criteria

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

I currently have cancer.

I cannot undergo photopheresis due to health reasons.

Treatment Details

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.

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.