Cell Therapy for Intestinal Transplant Recipients
Trial Summary
What is the purpose of this trial?
The purpose of this study is to investigate the safety and feasibility of giving intestinal transplant patients CD34+ stem cells (the cells that make all the types of blood cells) obtained from their organ donor's bone marrow. The goal of this is to develop a post-transplant treatment strategy that controls rejection while reducing the high risk of infection and malignant disease associated with the high levels of immunosuppression medication(s) that intestinal and multi-organ transplant patients must take. Infusion of bone marrow cells from the same donor of the transplanted organ(s) could promote a state called "mixed chimerism" in which both donor cells and recipient cells coexist in the body with the ultimate goal of minimizing the amount of immunosuppression medication(s) needed.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study aims to reduce the amount of immunosuppression medication needed, it's possible that changes to your medication regimen might be part of the trial.
What data supports the effectiveness of the treatment CD34+ stem cells, Hematopoietic Stem Cells, Bone Marrow-Derived Stem Cells for intestinal transplant recipients?
Research shows that hematopoietic stem cells (HSCs) in intestinal transplants can help promote immune tolerance, which is important for transplant success. Additionally, bone marrow-derived cells (BMDCs) can transform into intestinal cells and aid in repairing damaged tissue, potentially improving transplant outcomes.12345
Is cell therapy using CD34+ stem cells safe for humans?
How is the CD34+ stem cell treatment different from other treatments for intestinal transplant recipients?
The CD34+ stem cell treatment is unique because it uses specific stem cells from the bone marrow that have the ability to support blood cell production and potentially reduce immune reactions, which may help in better engraftment and tolerance in transplant recipients compared to other treatments.1112131415
Research Team
Tomoaki Kato, MD
Principal Investigator
Columbia University
Eligibility Criteria
This trial is for adults aged 18-65 who need an intestinal transplant and can follow up for 48 months. It's open to those listed in UNOS, with conditions like Short Bowel Syndrome or specific tumors, but not for those with multi-organ failure, severe infections, or unstable health conditions. Pregnant women and individuals unable to use birth control are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Transplantation and Initial Treatment
Participants undergo intestinal transplantation and receive an infusion of donor CD34+ stem cells between post-operative day 11 to day 13
Follow-up
Participants are monitored for safety, effectiveness, and occurrence of GVHD after transplantation
Long-term Monitoring
Participants are monitored for retention and graft survival
Treatment Details
Interventions
- CD34+ stem cells
CD34+ stem cells is already approved in United States, European Union for the following indications:
- Autologous use in hematopoietic stem cell transplantation for certain conditions such as leukemia and lymphoma
- Investigational use in intestinal transplantation for minimizing immunosuppression
- Autologous use in hematopoietic stem cell transplantation for certain conditions such as leukemia and lymphoma
- Investigational use in various clinical trials including intestinal transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Ossium Health, Inc.
Industry Sponsor