NCT05075811

Study of Ossium Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in the Setting of Crohn's Disease

Terminated Phase 1, PHASE2 Last updated 16 April 2026

What this trial tests

Phase 1, PHASE2 trial testing Ossium vBM-MSC in Pouch, Ileal in 20 participants. Terminated before completion.

Timeline

1 February 2022

Primary endpoint
15 November 2024

15 November 2024

Quick facts

Lead sponsor	Anthony Lembo
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	1 February 2022
Primary completion	15 November 2024
Estimated completion	15 November 2024
Sites	1 location across United States

Drugs / interventions tested

• Ossium vBM-MSC — full drug profile →
• Placebo

Conditions studied

• Pouch, Ileal — all drugs for Pouch, Ileal →
• Fistula — all drugs for Fistula →

Sponsor

Anthony Lembo

Who can join

Adults 18 to 75, any sex, with Pouch, Ileal or Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the safety and feasibility of using Ossium vertebral Bone Marrow Derived Mesenchymal Stem Cells (vBM-MSC) to treat people with an ileal pouch anal anastomosis (IPAA) who develop a fistula in the setting of Crohn's disease of the pouch.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic potential of mesenchymal stem/stromal cells (MSCs)-based cell therapy for inflammatory bowel diseases (IBD) therapy.
   Saadh MJ, Mikhailova MV, Rasoolzadegan S, Falaki M, et al · · 2023 · cited 45× · PMID 36707899 · DOI 10.1186/s40001-023-01008-7
2. Systematic review and meta-analysis of the efficacy and safety of stem cell treatment of anal fistulas.
   Emile SH, Dourado J, Rogers P, Wignakumar A, et al · · 2025 · cited 5× · PMID 40205247 · DOI 10.1007/s10151-025-03138-y