New York, NYNCT04804891Now EnrollingIRB Ready

Intestinal Transplantation Clinical Trial in New York, NY

Access cutting-edge intestinal transplantation treatment through this phase 1 clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Columbia University

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Expert Care in New York

Access intestinal transplantation specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related intestinal transplantation treatment provided free

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Check if you qualify for this intestinal transplantation clinical trial in New York, NY

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Intestinal Transplantation Study in New York

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.

Sponsor: Columbia University

Who Can Participate

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
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT04804891) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Intestinal Transplantation Treatment Options in New York, NY

If you're searching for intestinal transplantation treatment options in New York, NY, this clinical trial (NCT04804891) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced intestinal transplantation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all intestinal transplantation clinical trials near you to find additional studies recruiting in your area.

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