What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease include glucocorticoids, thiopurines (azathioprine, 6-mercaptopurine), and biologic agents (anti-TNF agents). Glucocorticoids can cause side effects such as weight gain, osteoporosis, and increased infection risk. Thiopurines may lead to bone marrow suppression, liver toxicity, and increased risk of infections. Biologic agents can cause infusion reactions, increased risk of infections, and potential development of antibodies against the drug. For treatments similar to Mesenchymal Stem Cells (MSCs) like Darvadstrocel, the known side effects are generally minimal but can include local site reactions and a low risk of infection. However, the efficacy and long-term safety of MSCs require further study.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of Crohn's Disease, which are somewhat similar to the mesenchymal stem cell therapy being studied in the trial Darvadstrocel. These include anti-TNF agents like infliximab (Remicade), adalimumab (Humira), and golimumab (Simponi), which target tumor necrosis factor-alpha to reduce inflammation. Vedolizumab (Entyvio), an integrin receptor antagonist, and ustekinumab (Stelara), an IL-12 and IL-23 inhibitor, are also approved for moderate to severe Crohn's Disease. These biologics work by modulating the immune response, similar to how MSCs aim to repair tissue and reduce inflammation.

What other types of research exist?

Promising novel alternatives to Darvadstrocel for Crohn's Disease patients include allogeneic umbilical cord-derived mesenchymal stem cells, which have potential for cartilage and bone regeneration and may be applicable for tissue repair in Crohn's Disease. Additionally, decellularized extracellular matrix (ECM) scaffolds, such as those derived from diaphragm or small intestinal submucosa, show potential for promoting tissue regeneration and could be explored for Crohn's Disease treatment.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 104 and 156

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

Acrochordon

Cheilitis

Dental caries

Fistula

Nausea

Pharyngitis

Pyrexia

Rhinitis

Calculus urinary

Intestinal anastomosis complication

Intestinal obstruction

Premature labour

Small intestinal obstruction

Tubulointerstitial nephritis

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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.