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Stem Cell Therapy

Long-term Follow-up with Darvadstrocel for Perianal Fistula

Phase 3
Waitlist Available
Research Sponsored by Millennium Pharmaceuticals, Inc.
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 weeks 104 and 156
Awards & highlights

Study Summary

This trial will not give participants any drugs; instead, researchers will observe and track any long-term side effects or improvements in symptoms from a previous trial of Darvadstrocel in the treatment of complex perianal fistulas.

Who is the study for?
This trial is for adults who have completed the ADMIRE-CD II study without dropping out, aimed at those with complex perianal fistulas often associated with Crohn's Disease. Participants must join within 3 months of completing the previous study.Check my eligibility
What is being tested?
The trial is not testing a new treatment but is focused on long-term follow-up to monitor side effects and symptom improvement in patients who were treated with Darvadstrocel for complex perianal fistula.See study design
What are the potential side effects?
Since no drug will be administered during this follow-up study, there are no direct side effects being tested. However, it will gather data on any long-term side effects from prior Darvadstrocel treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 104 and 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 104 and 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events (AEs)
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With Specific Adverse Events of Special Interest (AESIs)
Secondary outcome measures
Change from Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
Change from Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156
+4 more

Side effects data

From 2023 Phase 3 trial • 22 Patients • NCT03706456
27%
Proctalgia
18%
Nasopharyngitis
14%
Anal fistula
5%
Crohn's disease
5%
Intestinal obstruction
5%
Intestinal anastomosis complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Darvadstrocel 24 mL

Trial Design

1Treatment groups
Experimental Treatment
Group I: DarvadstrocelExperimental Treatment1 Intervention
Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally or darvadstrocel matching placebo previously in the ADMIRE-CD II study will be observed for efficacy and safety. No drug administration in this study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darvadstrocel
2019
Completed Phase 3
~110

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,763 Total Patients Enrolled
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,111 Total Patients Enrolled
Medical DirectorStudy DirectorMillennium Pharmaceuticals, Inc.
2,777 Previous Clinical Trials
8,063,335 Total Patients Enrolled

Media Library

Darvadstrocel (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04075825 — Phase 3
Crohn's Disease Research Study Groups: Darvadstrocel
Crohn's Disease Clinical Trial 2023: Darvadstrocel Highlights & Side Effects. Trial Name: NCT04075825 — Phase 3
Darvadstrocel (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04075825 — Phase 3

Frequently Asked Questions

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

Has Darvadstrocel been cleared by the FDA?

"Data from past clinical trials support the safety of Darvadstrocel, so it received a score of 3."

Answered by AI

Are there any precedents for this cell therapy?

"The first study evaluating the use of darvadstrocel was completed in 2017 at Klinikum der Johann Wolfgang Goethe-Universitat. As of now, there have been a total of 3 completed trials. Currently, there are 5 active trials being conducted; several of these are based in Salt Lake City, Utah."

Answered by AI

Are there any room for more test subjects in this research?

"This particular clinical trial has ceased recruitment. The trial was first announced on November 4th, 2019 but was most recently updated on April 9th, 2022. If you are looking for similar studies, 356 clinical trials for fistula and 5 for Darvadstrocel are presently enrolling participants."

Answered by AI

Could you tell me how many hospitals are a part of this clinical trial?

"There are currently 32 sites enrolling patients for this clinical trial. A few notable locations include Salt Lake City, Seattle and Charlottesville. You may want to choose the closest location to you to cut down on travel time, if you choose to participate."

Answered by AI

Darvadstrocel is used to treat what kind of condition?

"Darvadstrocel is an effective medical intervention for patients struggling with complex perianal fistula, Crohn disease, and other anal fistulas."

Answered by AI

What other similar trials have been done in the past?

"Tigenix S.A.U. ran the first Darvadstrocel clinical trial in 2017 with 554 participants. The success of this Phase 3 trial led to the drug's approval. There are currently 5 ongoing studies for Darvadstrocel being conducted in 119 cities and 18 nations."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
2019. "Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04075825.
All > Anal Fistula
~28 spots leftby Apr 2025
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