Status:
RECRUITING
Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Ossium Health, Inc.
Conditions:
Intestinal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Abdominal trauma, congenital abnormalities and ischemic injury cause intestinal damage that prevents the digestion and absorption of fluids and nutrients essential for life. Intestinal transplantation...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04804891
Start Date
October 22 2021
End Date
December 1 2028
Last Update
March 27 2025
Active Locations (1)
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1
Columbia University Irving Medical Center/NYP
New York, New York, United States, 10032