ECP + MSC Infusion for Graft-versus-Host Disease

Overseen By Molly Gallogly, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Molly Gallogly

Must be taking: Steroids

Disqualifiers: Active malignancy, Uncontrolled illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

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.

Research Team

Molly Gallogly, MD, PhD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

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

Hct > 27 and plts > 50,000 x10^9/L

I have received a stem cell transplant from a donor.

Participants must have the ability to understand and the willingness to sign a written informed consent document

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of Extracorporeal Photopheresis (ECP) and Mesenchymal Stem Cell (MSC) infusion for a single 28-day cycle

4 weeks

2-3 visits per week for ECP, 1-3 visits for MSC infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Allogeneic Mesenchymal Stromal Cells (MSCs)
• Extracorporeal Photopheresis (ECP)

Trial Overview 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.

Participant Groups

Group I: MSCs + ECP Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Molly Gallogly

Lead Sponsor

Trials

2

Recruited

70+