Actively Recruiting
Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation
Led by Columbia University · Updated on 2026-04-01
6
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
O
Ossium Health, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Actively listed as a candidate for intestinal or multi-visceral transplant at the study site
- Includes patients with conditions such as Short Bowel Syndrome, gastroschisis, volvulus, necrotizing enterocolitis, intestinal atresia, Crohn's disease, Hirschprung's disease, chronic intestinal pseudo-obstruction, malabsorption diseases, slow-growing low-malignancy tumors, and re-transplant candidates
- Commitment to planned follow-up at the study site for 48 months
- Age between 18 and 65 years old
- Able to sign informed consent themselves
You will not qualify if you...
- Active systemic infection with hemodynamic instability or sepsis
- Known immunodeficiency syndrome
- Carcinoma with metastasis except neuro-endocrine tumors
- Severe cardiovascular or respiratory instability requiring pressors or ventilator
- Severe cerebral edema with radiologic evidence
- Poorly controlled hypertension, diabetes, or uncontrollable seizure disorders
- Age over 65 years
- History of non-compliance with medical therapy or follow-up
- Substance addiction in the last six months
- Psychosocial instability or lack of social support
- Significant psychiatric disorders interfering with cooperation
- Severely limited functional status with poor rehabilitation potential
- Multi-organ failure before CD34+ infusion
- High pre-formed panel reactive antibodies (PRA) mean fluorescein intensity above 5000
- Pregnancy, breastfeeding, or intention to become pregnant during study
- Moderate or severe rejection before post-transplant day 11
- Vulnerable populations such as incarcerated or institutionalized individuals
- Clinical features suggestive of graft-versus-host disease
- Hemodynamic instability requiring vasopressors
- Female subjects of childbearing age and male patients not using effective birth control
- History of previous hematopoietic progenitor cell infusion or transplant of any kind
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center/NYP
New York, New York, United States, 10032
Actively Recruiting
Research Team
C
Clinical Research Core
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here