Long-term Follow-up with Darvadstrocel for Perianal Fistula

Recruiting at 104 trial locations

Overseen By Takeda Study Registration Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Millennium Pharmaceuticals, Inc.

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

150 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but since participants will not receive any drug in this study, it seems unlikely that you would need to stop.

What data supports the effectiveness of the treatment Darvadstrocel for perianal fistulas?

Darvadstrocel, a treatment using stem cells, has been shown to be effective in closing complex perianal fistulas in patients with Crohn's disease, with more than half of the patients maintaining remission after one year. It is a promising option for those who have not responded well to other treatments. ^{1 2 3 4 5}

How is the treatment Darvadstrocel unique for perianal fistulas in Crohn's disease?

Darvadstrocel is unique because it is the first stem cell therapy approved for treating complex perianal fistulas in Crohn's disease, using mesenchymal stem cells derived from adipose tissue to promote healing. It is administered directly into the fistula areas, offering a novel, minimally invasive option for patients who have not responded to other treatments. ^{1 2 3 4 5}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Long-term Follow-up

Participants are monitored for long-term safety and efficacy of darvadstrocel without receiving any drug

104 weeks

Multiple visits to the clinic and telephone follow-up every 3 months

Open-label Extension

Participants continue in the treatment group assigned in the ADMIRE-CD II study for further observation

104 weeks

Treatment Details

Interventions

• Darvadstrocel

Trial Overview 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.

Participant Groups

Group I: Darvadstrocel Experimental Treatment 1 Intervention

Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

Group II: Placebo Placebo Group 1 Intervention

Participants who received darvadstrocel placebo-matching expanded adipose-derived stem cells (eASCs) intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

Who Is Running the Clinical Trial?

Millennium Pharmaceuticals, Inc.

Lead Sponsor

Trials

406

Recruited

46,900+

Dr. Christophe Bianchi

Millennium Pharmaceuticals, Inc.

Chief Medical Officer since 2006

MD from University of Geneva

Dr. Deborah Dunsire

Millennium Pharmaceuticals, Inc.

Chief Executive Officer since 2005

MD from University of Witwatersrand

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

References

1. England pubmed.ncbi.nlm.nih.gov

Allogenic stem cells for Crohn's anal fistulas: Treating early improves the deep remission rate. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Darvadstrocel for the treatment of perianal fistulas in Crohn's disease. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Darvadstrocel for the treatment of patients with perianal fistulas in Crohn's disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn's Disease Treated in the ADMIRE-CD Trial. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Darvadstrocel: A Review in Treatment-Refractory Complex Perianal Fistulas in Crohn's Disease. [2019]