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Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)

NCT04847739 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-01

No results posted yet for this study

Summary

A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm.

The study has 2 parts:

Part 1: All required study visits for subjects who initially receive study treatment and those who receive standard of care therapy (control arm).

Part 2: Subjects who are enrolled in the control arm may receive treatment with AVB-114 following week 36. Those subjects then will be followed as specified in the clinical protocol.

Conditions

Interventions

PROCEDURE

Seton Placement

This treatment consists of inserting a seton (a soft flexible tube or nonabsorbable string) into the subject's perianal fistula. The seton will be removed by a study doctor at study visits as applicable.

DRUG

AVB-114

AVB-114 consists of stem cells taken from a subject's fat tissue seeded into a bioabsorbable plug. AVB-114 will be inserted into the subject's fistula by a study doctor on Day 0.

Sponsors & Collaborators

  • Alimentiv Inc.

    collaborator OTHER

  • Avobis Bio, LLC

    lead INDUSTRY

Principal Investigators

  • Joan Morris · Alimentiv Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2025-05-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847739 on ClinicalTrials.gov