Extracorporeal Photopheresis and Mesenchymal Stem Cell Infusion for GVHD
NCT05333029 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2025-01-07
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
Allogeneic mesenchymal stromal cells (MSCs)
Treatment dose 2 x10\^6 cells/kg (+/- 20%)
- BIOLOGICAL
-
Extracorporeal photopheresis (ECP)
Blood is collected through an intravenous (IV) line which is connected to an apheresis machine.The machine adds a chemical that makes the white blood cells sensitive to light. Then the machine shines a light on the cells and then returns the blood to the participant
Sponsors & Collaborators
-
Molly Gallogly
lead OTHER
Principal Investigators
-
Molly Gallogly, MD, PhD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-01
- Primary Completion
- 2024-12-01
- Completion
- 2025-06-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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