Stem Cell Transplant for Crohn's Disease
Trial Summary
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it mentions that participants should have an unsatisfactory response to certain immunosuppressive drugs. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment Peripheral Blood Stem Cell Infusion for Crohn's Disease?
Peripheral Blood Stem Cell Infusion has shown benefits in other conditions, such as faster recovery of blood cells after high-dose chemotherapy, which reduces hospital stays and the need for blood transfusions. This suggests it might help in conditions like Crohn's Disease by promoting quicker recovery and reducing complications.12345
Is stem cell transplant generally safe for humans?
Stem cell transplants, including peripheral blood stem cell infusions, can cause some adverse reactions like vomiting and transient shock, but these are usually manageable and not life-threatening. Serious adverse events are rare, occurring in less than 1% of donors, and there have been no fatalities reported in the studies reviewed.678910
How is the stem cell transplant treatment different from other treatments for Crohn's disease?
Stem cell transplant for Crohn's disease is unique because it involves using the patient's own stem cells to reset or modify the immune system, potentially leading to remission. Unlike standard treatments that mainly focus on managing symptoms, this approach aims to address the underlying immune dysfunction.1112131415
What is the purpose of this trial?
Unfortunately, some patients with Crohn's disease (CD) fail to respond to the best clinical treatments and some only experience temporary benefit. For severe Crohn's disease, there is an experimental treatment called "high dose immunoablation" followed by autologous hematopoietic stem cell transplantation (HSCT). This study removes over active lymphocytes (immunoablation) and replaces them using blood stem cells that have been taken from the patient's own body. The aim of the study is to reset or reprogram the patient's immune system to its state prior to diagnosis.
Research Team
David Ziring, MD
Principal Investigator
Cedars-Sinai Medical Center
Eligibility Criteria
This trial is for young people aged 13-28 with severe Crohn's Disease, who haven't responded well to at least three immunosuppressive drugs and steroids. They must have active disease, be informed about the risks, and not suitable for surgery or at risk of short bowel syndrome. Pregnant individuals or those unwilling to use contraception are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Mobilization and Conditioning
Participants undergo stem cell mobilization and conditioning prior to transplantation
Stem Cell Transplantation
Participants receive autologous hematopoietic stem cell transplantation
Post-Transplant Conditioning
Participants receive post-transplant conditioning to support engraftment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Peripheral Blood Stem Cell Infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor