ECMT-100 for Anal Fistulas

Overseen By Cynthia Berringer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ECM Therapeutics, Inc.

Must not be taking: Antiplatelet drugs

Disqualifiers: Crohn's, Ulcerative colitis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ECMT-100 to determine its safety and effectiveness for people with anorectal fistulas. Anorectal fistulas are painful tunnels that form between the end of the bowel and the skin near the anus. The trial seeks participants with a specific type of fistula that has one internal and one or two external openings and who have had a seton in place for at least three months. Researchers will follow participants for a year to monitor progress, and a second treatment may be provided if needed. As an unphased trial, this study offers a unique opportunity to contribute to the early understanding of a new treatment's potential benefits.

Will I have to stop taking my current medications?

The trial requires that you stop taking antiplatelet drugs 5 to 7 days before surgery. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that ECMT-100 is likely to be safe for humans?

Research has shown that ECMT-100 is being tested for its safety and effectiveness in treating anal fistulas. ECMT-100, a gel-like substance, is applied directly into the fistula tract to aid healing. The FDA has approved a study to evaluate its efficacy, indicating it is safe enough for human testing.

Although specific safety data from completed studies on ECMT-100 is not yet available, the approval for testing suggests that any risks are manageable. While side effects may occur, they are not expected to be serious or common. Testing in humans indicates a good safety profile, as treatments must meet certain safety standards before reaching this stage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for anal fistulas, which often include surgery or antibiotics, ECMT-100 is being explored as a non-surgical option. Researchers are excited about ECMT-100 because it offers a potentially less invasive approach, focusing on targeted delivery of treatment directly to the affected area. This could mean fewer side effects and a quicker recovery time compared to surgery. Additionally, the possibility of a repeat treatment as needed provides more flexibility in managing the condition effectively.

What evidence suggests that ECMT-100 might be an effective treatment for anal fistulas?

Research shows that ECMT-100, a special gel, helps treat anal fistulas by adhering to the gut lining and filling the fistula tract. Previous studies with similar treatments, such as a plug made from natural materials, showed about a 71.4% success rate in closing fistulas. Another study achieved a 100% healing rate with this type of treatment. These promising results suggest that ECMT-100, which participants in this trial will receive, could effectively heal anal fistulas. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific type of anal fistula, which has one internal and up to two external openings. Participants must have had a seton in place for at least three months and be willing to attend follow-up evaluations. Pregnant women or those unable to consent are excluded.

Inclusion Criteria

I have given my permission to participate after understanding the study.

I am willing to attend follow-up appointments after surgery.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

ECMT-100 is administered via catheter within the fistula tract following curettage of the tract

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits as determined by clinician

Repeat Treatment (optional)

Subjects are eligible for one repeat treatment as determined by the clinician/investigator at or prior to the 6-month visit

What Are the Treatments Tested in This Trial?

Interventions

• ECMT-100

Trial Overview The study tests the safety and effectiveness of ECMT-100, an ECM Hydrogel, in treating anorectal fistulas. It aims to see if this treatment can help heal the fistulas without causing significant complications.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

ECMT-100 Subjects will be followed for 12 months following last treatment with ECMT-100. Subjects are eligible for one repeat treatment as determined by the clinician/investigator at or prior to the 6-month visit.

Who Is Running the Clinical Trial?

ECM Therapeutics, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07035925

Study Evaluating the Safety and Efficacy of an ECM ... ECMT-100 is a mucoadhesive hydrogel composed of ECM formulated to adhere to the gastrointestinal mucosa, fill the transsphincteric fistula tract, and promote ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2776849/

Acellular extracellular matrix anal fistula plug Our study with Surgisis AFP in 21 patients with fistula-in-ano yielded a success rate of 71.4%. However, all of our patients had high fistulae[4] ...

3. trial.medpath.com trial.medpath.com/news/33da49da06407995/fda-approves-ide-for-ecm-therapeutics-novel-hydrogel-treatment-for-anorectal-fistulas

FDA Approves IDE for ECM Therapeutics' Novel Hydrogel ... ECM Therapeutics has received FDA Investigational Device Exemption approval for ECMT-100, a regenerative hydrogel derived from extracellular ...

4. ouci.dntb.gov.ua ouci.dntb.gov.ua/en/works/ley03aJl/

Long-term outcomes of an acellular dermal matrix for the ... High trans-sphincteric fistulae were observed in 52.9% of patients. At a median follow-up of 21.8 (8–36) months, a 53% success rate was achieved. Approximately ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2739342/

A anorectal fistula treatment with acellular extracellular matrix RESULTS: All of the 30 patients had successful closure of their fistula after a 7-14 d follow-up. The healing rate of anal fistula in treatment group was 100%.

6. synapse.patsnap.com synapse.patsnap.com/article/fda-approves-ecm-therapeutics-for-us-study-of-ecmt-100-in-anorectal-fistula-treatment

FDA Approves ECM Therapeutics for U.S. Study of ECMT ... This novel hydrogel is designed to treat anorectal fistulas, a condition that presents considerable challenges and affects between 70,000 to ...

7. ecmtherapeutics.com ecmtherapeutics.com/ecm-therapeutics-receives-fda-ide-approval-for-u-s-feasibility-study-of-ecmt-100-in-treatment-of-anorectal-fistulas/

ECM Therapeutics Receives FDA IDE Approval for U.S. ... ECM Therapeutics Receives FDA IDE Approval for U.S. Feasibility Study of ECMT-100 in Treatment of Anorectal Fistulas. May 6, 2025. FDA ...

8. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-study-evaluating-the-safety-and-efficacy-of-an-ecm-hydrogel-for-the-treatment-of-anorectal-fistulas/555738320

Clinical Trial: Study Evaluating the Safety and Efficacy of ... Brief Summary: Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas ... Condition: Fistula in Ano Intervention: DEVICE ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11982159/

Systematic review and meta-analysis of the efficacy and ... We hypothesized that the use of stem cells may be an effective and safe treatment of anal fistulas; however, the ultimate efficacy of stem cell ...