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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

AVB-114 is an investigational therapy which offers a new therapeutic approach to treating this unmet medical need. The drug product is a mesenchymal cell substrate system comprised of autologous mesenchymal cells incubated with a 3-dimensional bioabsorbable substrate. The drug substance is expanded, pure mesenchymal stem cells (MSC) which are known to modulate local inflammation and orchestrate tissue healing. By incubating cells with a 3-dimensional bioabsorbable substrate designed for anal fistula geometry, cells are locally delivered into the fistula tract to promote healing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04847739
Study type	Interventional
Source	Avobis Bio, LLC
Contact	Alimentiv Inc
Phone	416-898-5326
Email	STOMP2PM@alimentiv.com
Status	Recruiting
Phase	Phase 2
Start date	September 13, 2021
Completion date	May 2026

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03815851` - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery	N/A
Not yet recruiting	`NCT06100289` - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease	Phase 3
Completed	`NCT02883452` - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis	Phase 1
Recruiting	`NCT04777656` - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.	Phase 3
Terminated	`NCT03017014` - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting	`NCT05428345` - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Recruiting	`NCT06053424` - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease	Phase 1
Completed	`NCT02508012` - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases	N/A
Not yet recruiting	`NCT02858557` - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases	N/A
Terminated	`NCT02882841` - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients	N/A
Completed	`NCT03010787` - A First Time in Human Study in Healthy Volunteers and Patients	Phase 1
Terminated	`NCT02417974` - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)	Phase 2
Completed	`NCT02542917` - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Active, not recruiting	`NCT02316678` - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics	N/A
Completed	`NCT02154425` - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers	Phase 1
Completed	`NCT02193048` - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed	`NCT02265588` - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).	N/A
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Recruiting	`NCT02395354` - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease	N/A
Completed	`NCT01958827` - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease	Phase 3