NCT05407766

Mesenchymal Stem Cells (MSCs) for Perianal Fistula

A Phase I Safety Study of Allogeneic Bone Marrow Derived MSCs for Refractory Perianal Fistulizing Crohn's Disease

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ossium Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Fistula

Interventions

Type	Name	Description
BIOLOGICAL	OSSM-001	Single injection of OSSM-001 at dose of 100M or 300M cells
OTHER	Placebo	Single injection of placebo (saline)

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-04-01
• Completion: 2024-08-01
• First posted: 2022-06-07
• Last updated: 2022-12-23

Regulatory

• FDA-regulated drug study