RECRUITING

Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation

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Conditions

Intestinal TransplantationCD34+ stem cellsChimerismBone marrow stells

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation

Quick Facts

Study Start:2021-10-22
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04804891

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * Short Bowel Syndrome (SBS) due to:
  3. * Trauma (multiple resections/explorations and/or vascular abdominal trauma superior mesenteric artery (SMA) / superior mesenteric vein (SMV) injuries)
  4. * Gastroschisis
  5. * Volvulus
  6. * Necrotizing Enterocolitis
  7. * Intestinal Atresia
  8. * Crohn's Disease
  9. * Hirschprung's Disease
  10. * Chronic Intestinal Pseudo-Obstruction
  11. * Malabsorption:
  12. * Microvillus Inclusion Disease
  13. * Tufting Enteropathy
  14. * Complete portomesenteric thrombosis with cirrhosis
  15. * Slow-growing, low-malignancy potential tumors infiltrating mesenteric root:
  16. * Gardner's Syndrome
  17. * Familial Adenomatous Polyposis
  18. * Desmoid Tumor with Intra-Abdominal Infiltration
  19. * Endocrine Tumors
  20. * 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)
  21. * Patient commits to planned follow up at a study site for the 48-month duration of study procedures
  22. * Age ≥18 years old and ≤65 years old
  23. * Subjects or capable of signing the informed consent document themselves
  1. * Active systemic infection with hemodynamic instability and/or sepsis
  2. * Patients with known immunodeficiency syndrome
  3. * Carcinoma with metastasis (except neuro-endocrine tumors, even in the presence of metastasis these patients may undergo multivisceral/cluster transplantation)
  4. * Severe cardiovascular and/or respiratory instability, as defined by requirement of pressors or ventilator
  5. * Severe cerebral edema, with radiologic findings of effaced sulci and/or herniation
  6. * Poorly controlled hypertension (systolic blood pressure \> 170 on at least 2 occasions), diabetes mellitus (HbA1c \> 8), or uncontrollable seizure disorders
  7. * Age \> 65 years
  8. * Documented history of non-compliance with medical therapy and follow-up
  9. * Substance addiction in the last six months
  10. * Psychosocial Instability: absence of a consistent reliable social support system
  11. * Significant or active psychiatric disorder associated with the inability to cooperate or comply with medical therapy
  12. * In the judgement of the clinical team, severely limited functional status with poor rehabilitation potential
  13. * Multi-organ failure and preceding CD34+ infusion
  14. * Pre formed panel reactive antibodies (PRA) mean fluorescein intensity (MFI) \> 5000 by Luminex
  15. * Patients who are pregnant or breast-feeding or intend to get pregnant during the study period
  16. * Patients who have developed moderate or severe rejection before post-transplant day 11
  17. * Vulnerable populations, such as incarcerated or institutionalized individuals
  18. * Subjects with clinical features suggestive of GVHD
  19. * Subjects who are hemodynamically unstable (i.e., requiring vasopressor support)
  20. * 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
  21. * 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

Contacts and Locations

Study Contact

Clinical Research Core
CONTACT
212-305-3839
tk2388@cumc.columbia.edu

Principal Investigator

Tomoaki Kato, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center/NYP
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Tomoaki Kato, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-22
Study Completion Date2028-12

Study Record Updates

Study Start Date2021-10-22
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • CD34+ stem cells
  • Chimerism
  • Bone marrow stells

Additional Relevant MeSH Terms

  • Intestinal Transplantation