Mesenchymal Stem Cells (MSCs) for Perianal Fistula

Status Withdrawn

Clinical Trial Summary

OSSM-001 will be evaluated in a double blind, randomized phase I safety study of a single injection of 100 and 300 million bone marrow derived MSCs in 16 patients with refractory perianal fistulas in the setting of Crohn's disease. There will be 2 cohorts (100M and 300M MSCs); 8 subjects in each cohort; 6 subjects receiving the investigational product and 2 subjects receiving placebo (normal saline) in each cohort.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05407766
Study type	Interventional
Source	Ossium Health, Inc.
Contact
Status	Withdrawn
Phase	Phase 1
Start date	August 2022
Completion date	August 2024

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02423330` - A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula	Early Phase 1
Withdrawn	`NCT02678936` - Anal Fistula Repair With Platelet-rich Plasma	Phase 4
Recruiting	`NCT01997645` - Surgical Treatment of High Perianal Fistulas	N/A
Completed	`NCT04844593` - A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease
Recruiting	`NCT01615302` - Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?	N/A
Recruiting	`NCT05390151` - Laser Assisted Treatment of Fistula In Ano	N/A
Completed	`NCT02402543` - Pre-Emptive Analgesia in Ano-Rectal Surgery	N/A
Completed	`NCT04876690` - A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas
Completed	`NCT03864718` - Photodynamic Therapy in Anal Fistula
Active, not recruiting	`NCT00517296` - Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas	N/A