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New treatment option for Intestinal Transplantation
Official title Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation
ClinicalTrials.gov ID: NCT04804891
What this study is testing
What is Cell Therapy?
Cell Therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intestinal transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- All patients actively listed as candidates for intestinal or multi-visceral transplant at the study site; while all patients who are actively listed...
- 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
You likely can't join 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...
- 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...
See the full eligibility 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...
- 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
- people or capable of signing the informed consent document themselves
- 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
- people with clinical features suggestive of GVHD
- people who are hemodynamically unstable (i.e., requiring vasopressor support)
- Female people 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.