Long-term Follow-up with Darvadstrocel for Perianal Fistula

Recruiting in Palo Alto (17 mi)

+104 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Millennium Pharmaceuticals, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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.

Inclusion Criteria

Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).

Exclusion Criteria

Has been more than 3 months since the participant completed the ADMIRE-CD II study.

Treatment Details

Interventions

Darvadstrocel (Stem Cell Therapy)

Trial OverviewThe 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.

Participant Groups

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.