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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
No Placebo-Only Group
Pivotal Trial

Summary

This trial is studying the effects of Darvadstrocel, a treatment using special cells to heal difficult wounds in adults with Crohn's Disease. The treatment works by using stem cells to repair tissue and reduce inflammation. Darvadstrocel is a stem cell therapy derived from adipose tissue, used to treat complex perianal fistulas in Crohn's Disease.

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 Relapse
+3 more

Side effects data

From 2023 Phase 3 trial • 22 Patients • NCT03706456
32%
Proctalgia
27%
Anal fistula
27%
Nasopharyngitis
18%
COVID-19
14%
Crohn's disease
14%
Back pain
9%
Acrochordon
9%
Cheilitis
9%
Dental caries
9%
Fistula
9%
Nausea
9%
Pharyngitis
9%
Pyrexia
9%
Rhinitis
5%
Calculus urinary
5%
Intestinal anastomosis complication
5%
Intestinal obstruction
5%
Premature labour
5%
Small intestinal obstruction
5%
Tubulointerstitial nephritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Darvadstrocel 24 mL

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~260

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Crohn's Disease include anti-inflammatory drugs, immunosuppressants, biologics, and mesenchymal stem cells (MSCs). Anti-inflammatory drugs like corticosteroids reduce inflammation by suppressing the immune response. Immunosuppressants such as azathioprine and methotrexate inhibit the immune system to prevent ongoing inflammation. Biologics, including anti-TNF agents, target specific proteins involved in the inflammatory process to reduce symptoms and promote healing. Mesenchymal stem cells (MSCs), like those in Darvadstrocel, are believed to aid in tissue repair by modulating the immune response and promoting regeneration at the site of injury. This is particularly important for Crohn's Disease patients as it offers a potential treatment for complex perianal fistulas, a common and challenging complication of the disease.

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,757 Total Patients Enrolled
TakedaLead Sponsor
1,238 Previous Clinical Trials
4,149,047 Total Patients Enrolled
Medical DirectorStudy DirectorMillennium Pharmaceuticals, Inc.
2,892 Previous Clinical Trials
8,089,171 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
~25 spots leftby Dec 2025