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NCT03219359 · ClinicalTrials.gov registry record · Phase 2
Autologous Stem Cell Transplant for Crohn's Disease
A Phase 2 study of Crohn Disease, sponsored by Aaron Etra.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03219359: Recruiting Phase 2 study of Crohn Disease, sponsored by Aaron Etra.
NCT03219359 is a Phase 2 study of Crohn Disease that is actively recruiting participants, run by Aaron Etra. The registered enrollment target is 50 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03219359, a Phase 2 study of Crohn Disease, is actively recruiting participants, sponsored by Aaron Etra.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Crohn's Disease (CD) is an inflammatory bowel disease. It can lead to significant complications and discomfort in the stomach and intestines. Crohn's disease is a debilitating, incurable disease of immune cells; it affects almost 1 million people in the United States. CD is characterized by inflammation of the stomach and intestine as well as organs outside of the intestines such as the skin, eyes, and joints. Current therapies to treat CD aim to suppress the patient's immune cells but these therapies become ineffective for the majority of patients and lead to complications including the requirement for surgical bowel resection, impaired quality of life, and lifelong disability. Hematopoietic stem cell transplantation (HCT) is a procedure used to treat a number of medical conditions including Crohn's disease. To improve success of HCT in CD doctors considered combining transplant with other drugs to improve the chances of achieving remission and also maintaining the remission. The Investigators' plan in this study is to incorporate the drug Vedolizumab after transplant to test if this drug will improve remission and make patients healthier. Patients may qualify to take part in this research study because Crohn's disease is active, because surgery is not a treatment option and because there is evidence that the disease has failed to respond to treatments for Crohn's disease including the following: * corticosteroids * azathioprine, 6-mercaptopurine, methotrexate * Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab) * Anti-integrin agents (natalizumab, Vedolizumab) If patients meet entry criteria will undergo a baseline endoscopy, colonoscopy and MR or CT enterography. If documentation of active mucosal disease patients will then be tapered off of current medications and undergo stem cell mobilization. Mobilization will involve low dose chemotherapy, growth factors and require 1-2 week hospitalization. Patients will then undergo stem cell transplant which wi
Primary Outcome
The proportion of patients in clinical remission, defined as a CDAI \< 150, one year after autologous HCT from 45% to 65% as compared to baseline.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Thymoglobulin
- DRUG Methylprednisolone
- PROCEDURE Autologous stem cell transplant
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-02-22 |
| Est. Completion | 2028-10 |
| Phase | Phase 2 |
What NCT03219359 shows while recruiting
NCT03219359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03219359 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03219359 about?
NCT03219359 is a clinical study titled "Autologous Stem Cell Transplant for Crohn's Disease". Crohn's Disease (CD) is an inflammatory bowel disease. It can lead to significant complications and discomfort in the stomach and intestines. Crohn's disease is a debilitating, incurable disease of immune cells; it affects almost 1 million people in the United States. CD is characterized by inflamma...
What is the current status of trial NCT03219359?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2018-02-22. Estimated completion is 2028-10.
What conditions does trial NCT03219359 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT03219359?
The interventions under investigation include: Cyclophosphamide (DRUG), Thymoglobulin (DRUG), Methylprednisolone (DRUG), Autologous stem cell transplant (PROCEDURE).
Who is sponsoring clinical trial NCT03219359?
This trial is sponsored by Aaron Etra, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03219359 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
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03219359's enrollment target sits among peer trials
50 48th of 71 higher than 22 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease 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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