Recruiting
Phase 1

T-Cell Alloreactivity

Sponsor:

Columbia University

Code:

NCT04804891

Conditions

Intestinal Transplantation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cell Therapy

Study Details

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 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

Intestinal Transplantation

Study ID

NCT04804891

Start date

Oct 22, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

6 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cell Therapy

Patients will receive an infusion containing 1x106/kg CD34+ cells. No more than 104 CD34+ T cells per kg recipient weight will be included in the infusion. Cadaveric donor CD34 cell infusion will occur at any time between post-operative day 11 to day 13 following transplantation.

no intervention: Control

Patients who do not consent to receive donor CD34 cell infusion or whose donor family declines consent for research use of donor bone marrow will receive their usual standard of care.

Interventions

Cell Therapy

Infusion of containing 1x106/kg CD34+ cells from donor bone marrow selected using the CliniMACS® CD34 Reagent System.

Primary outcome measure

  • Total number of participants with moderate to severe GVHD [ Time Frame: Up to 4 years after transplantation ]

Central Contacts and Locations

Central contacts

Clinical Research Core

212-305-3839tk2388@cumc.columbia.edu

Locations

Columbia University Irving Medical Center/NYP

Recruiting

New York, New York, United States, 10032

Contacts

Clinical Research Core

212-305-3839tk2388@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • CD34+ stem cells
  • Chimerism
  • Bone marrow stells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-01.