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Stem Cell Therapy

Cx601 for Crohn's Disease (ADMIRE-CD-II Trial)

Phase 3
Waitlist Available
Research Sponsored by Tigenix S.A.U.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed (up to week 52)
Awards & highlights

ADMIRE-CD-II Trial Summary

This trial is designed to see if the treatment can close all external openings of complex perianal fistulas and reduce the size of any collections by at least 2 cm.

Eligible Conditions
  • Crohn's Disease

ADMIRE-CD-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed (up to week 52)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed (up to week 52) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Combined Remission at Week 24
Secondary outcome measures
Number of Participants With TEAEs Related to Clinical Laboratory Parameters
Number of Participants With TEAEs Related to Vital Sign Parameters
Therapeutic procedure
+10 more

ADMIRE-CD-II Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cx601Experimental Treatment1 Intervention
Cx601 eASCs 120 million cells (5 million cells per milliliter [mL]) will be administered once by intralesional injection.
Group II: PlaceboPlacebo Group1 Intervention
CX601 placebo-matching eASCs cells will be administered once by intralesional administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cx601
2017
Completed Phase 3
~880

Find a Location

Who is running the clinical trial?

Tigenix S.A.U.Lead Sponsor
10 Previous Clinical Trials
911 Total Patients Enrolled
Medical DirectorStudy DirectorTakeda
2,777 Previous Clinical Trials
8,062,911 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary conditions that Cx601 is indicated for?

"Cx601 can be used to treat complex perianal fistula, crohn disease, and therapeutic procedure."

Answered by AI

Does Cx601 have many potential side effects for patients?

"Cx601's safety is reflected by its Phase 3 status, and thus it received a score of 3."

Answered by AI

Are there any current vacancies for subjects in this experiment?

"Unfortunately, this study is not looking for new patients at this time. According to the information available on clinicaltrials.gov, the trial was posted on September 15th, 2017 and last updated on August 18th, 2022. Although this specific trial has completed recruitment, there are still 357 other trials that are currently looking for participants."

Answered by AI

Are there many different places in Canada where this test is being administered?

"Currently, patients are being enrolled at Weill Medical College of Cornell University, NYU Langone Medical Center, Dartmouth Hitchcock Medical Center - Cancer Center, as well as 75 other locations."

Answered by AI

What other investigatory work has been done on Cx601?

"Cx601 was first trialled in 2017 at the Morristown Medical Center - Gastroenterology. Since then, a total of 18,243 clinical trials have been completed. Currently, 5 studies are actively recruiting, with many of these based in New york City."

Answered by AI

What other similar trials preceded this one?

"Cx601 was first trialled in 2017 by Tigenix S.A.U. and has since undergone 5 Phase 3 clinical trials in 119 different cities across 18 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)
2017. "Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03279081.
~75 spots leftby Apr 2025
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