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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 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.

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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.

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

FieldValue
Enrollment Target 15 participants
Start Date 2019-11-15
Est. Completion 2027-09-30
Phase Phase 1

Sponsor

Cedars-Sinai Medical Center

339 total trials

What the Registry Record Tells You About NCT04224558

The ClinicalTrials.gov registry entry for NCT04224558 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (93% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.