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NCT04224558 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Transplantation in Crohn's Disease
A Phase 1 study of Crohn Disease, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04224558: Recruiting Phase 1 study of Crohn Disease, sponsored by Cedars-Sinai Medical Center.
NCT04224558 is a Phase 1 study of Crohn Disease that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 15 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04224558, a Phase 1 study of Crohn Disease, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Unfortunately, some patients with Crohn's disease (CD) fail to respond to the best clinical treatments and some only experience temporary benefit. For severe Crohn's disease, there is an experimental treatment called "high dose immunoablation" followed by autologous hematopoietic stem cell transplantation (HSCT). This study removes over active lymphocytes (immunoablation) and replaces them using blood stem cells that have been taken from the patient's own body. The aim of the study is to reset or reprogram the patient's immune system to its state prior to diagnosis.
Primary Outcome
Change mucosal healing as determined by the simple endoscopic score for crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each are measured on a scale of 0-3 and are summed to create a total score. For total score, 0-2 indicates remission, 3-6 indicates mild endoscopic activity, 7-15 indicates moderate endoscopic activity, and \> 15 indicates severe endoscopic activity.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Mesna
- PROCEDURE Leukapheresis
- DRUG Filgrastim
- PROCEDURE Apheresis catheter placement
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
What NCT04224558 shows while recruiting
NCT04224558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04224558 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04224558 about?
NCT04224558 is a clinical study titled "Stem Cell Transplantation in Crohn's Disease". Unfortunately, some patients with Crohn's disease (CD) fail to respond to the best clinical treatments and some only experience temporary benefit. For severe Crohn's disease, there is an experimental treatment called "high dose immunoablation" followed by autologous hematopoietic stem cell transplan...
What is the current status of trial NCT04224558?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-11-15. Estimated completion is 2027-09-30.
What conditions does trial NCT04224558 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT04224558?
The interventions under investigation include: Cyclophosphamide (DRUG), Mesna (DRUG), Leukapheresis (PROCEDURE), Filgrastim (DRUG), Apheresis catheter placement (PROCEDURE).
Who is sponsoring clinical trial NCT04224558?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04224558 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04224558's enrollment target sits among peer trials
15 66th of 71 higher than 4 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.
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