Mesenchymal Stem Cells (MSCs) for Perianal Fistula

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.

Timeline

Start

2022-08

Primary completion

2024-04

Completion

2024-08

Drugs

Indications