Evaluation of PROCHYMAL Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with moderate-to-severe Crohn’s disase that has not responded to steroids, immunosuppressants or biologic therapies.
This study is evaluating the safety and effectiveness of an experimental drug called Prochymal. The active ingredient in Prochymal is adult human stem cells that have been taken out of the bone marrow of healthy adult volunteers. The stem cells are purified and grown outside of the body using biotechnology. The cells may have both immunosuppressive and healing benefits in Crohn’s disease. The cells naturally migrate specifically to sites of inflammation, so it is expected that this will result in the delivery of cells to a participant’s bowel affected by Crohn’s disease.
Study participants will be randomly assigned to receive either:
- Prochymal, or
- Placebo (a dose that contains no cells)
Participants will receive doses of Prochymal/placebo in a vein in the arm 4 times over 2 weeks. Participants will be followed for 2 years.
Disease Status and/or Stage
Moderate to Severe Crohn's Disease
Sponsor
Osiris
Key Eligibility
- Men and women age 18 to 70
- Crohn's disease
- Has not responded to steroids, immunomodulators or biologic therapy
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Jill Roberts Center for Inflammatory Bowel Disease
- (212) 746-5077
Protocol ID
Osiris 603
Healthy Volunteers
As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.
Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
