Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation
Recruiting now · Phase 1
Conditions studied: Intestinal Transplantation
In brief
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.
Key facts
- Study ID
- NCT04804891
- Run by
- Columbia University
- People needed
- 6
- Starts
- 2021-10-22
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-04-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients actively listed as candidates for intestinal or multi-visceral transplant at the study site; while all patients who are actively listed in United Network for Organ Sharing (UNOS) for intestinal and/or multi-visceral transplantation, including those who have previously received a multi-visceral transplant and are re-listed, are eligible for participation, the following are examples of listing criteria suitable for enrollment in this clinical trial:
- Short Bowel Syndrome (SBS) due to:
- Trauma (multiple resections/explorations and/or vascular abdominal trauma superior mesenteric artery (SMA) / superior mesenteric vein (SMV) injuries)
- Gastroschisis
- Volvulus
- Necrotizing Enterocolitis
- Intestinal Atresia
- Crohn's Disease
- Hirschprung's Disease
- Chronic Intestinal Pseudo-Obstruction
- Malabsorption:
- Microvillus Inclusion Disease
- Tufting Enteropathy
- Complete portomesenteric thrombosis with cirrhosis
- Slow-growing, low-malignancy potential tumors infiltrating mesenteric root:
- Gardner's Syndrome
- Familial Adenomatous Polyposis
- Desmoid Tumor with Intra-Abdominal Infiltration
- Endocrine Tumors
- Re-transplant candidates who lost the first graft to rejection or patients who have higher risk of toxicity from chronic long term immunosuppression (i.e., patients with chronic kidney disease)
- Patient commits to planned follow up at a study site for the 48-month duration of study procedures
- Age ≥18 years old and ≤65 years old
- Subjects or capable of signing the informed consent document themselves
You may not qualify if…
- Active systemic infection with hemodynamic instability and/or sepsis
- Patients with known immunodeficiency syndrome
- Carcinoma with metastasis (except neuro-endocrine tumors, even in the presence of metastasis these patients may undergo multivisceral/cluster transplantation)
- Severe cardiovascular and/or respiratory instability, as defined by requirement of pressors or ventilator
- Severe cerebral edema, with radiologic findings of effaced sulci and/or herniation
- Poorly controlled hypertension (systolic blood pressure > 170 on at least 2 occasions), diabetes mellitus (HbA1c > 8), or uncontrollable seizure disorders
- Age > 65 years
- Documented history of non-compliance with medical therapy and follow-up
- Substance addiction in the last six months
- Psychosocial Instability: absence of a consistent reliable social support system
- Significant or active psychiatric disorder associated with the inability to cooperate or comply with medical therapy
- In the judgement of the clinical team, severely limited functional status with poor rehabilitation potential
- Multi-organ failure and preceding CD34+ infusion
- Pre formed panel reactive antibodies (PRA) mean fluorescein intensity (MFI) > 5000 by Luminex
- Patients who are pregnant or breast-feeding or intend to get pregnant during the study period
- Patients who have developed moderate or severe rejection before post-transplant day 11
- Vulnerable populations, such as incarcerated or institutionalized individuals
- Subjects with clinical features suggestive of GVHD
- Subjects who are hemodynamically unstable (i.e., requiring vasopressor support)
- Female subjects of childbearing age and male patients who are not using and/or unwilling to use an effective method of birth control for the duration of the trial activities
- History of previous hematopoietic progenitor cell (HPC) infusion or transplant of any kind. Note: Human leukocyte antigen (HLA) mismatch will not be one of the exclusion criteria
Where it is running
- Columbia University Irving Medical Center/NYP — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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