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NCT04804891 · ClinicalTrials.gov registry record · Phase 1
Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation
A Phase 1 study of Intestinal Transplantation, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04804891: Recruiting Phase 1 study of Intestinal Transplantation, sponsored by Columbia University.
NCT04804891 is a Phase 1 study of Intestinal Transplantation that is actively recruiting participants, run by Columbia University. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04804891, a Phase 1 study of Intestinal Transplantation, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Total number of participants with moderate to severe (at least Grade II) graft-versus-host disease (GVHD) will be monitored.
Conditions Studied
Interventions
- BIOLOGICAL Cell Therapy
Study Locations (1)
New York
- Columbia University Irving Medical Center/NYP - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-10-22 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT04804891 shows while recruiting
NCT04804891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Intestinal Transplantation appearing as the primary indexed condition, and to 1 intervention - of which Cell Therapy is the first listed.
NCT04804891 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04804891 about?
NCT04804891 is a clinical study titled "Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation". 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 ...
What is the current status of trial NCT04804891?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-10-22. Estimated completion is 2028-12.
What conditions does trial NCT04804891 study?
This clinical trial studies the following conditions: Intestinal Transplantation.
What interventions are being tested in trial NCT04804891?
The interventions under investigation include: Cell Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT04804891?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04804891 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04804891's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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