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

NCT05075811 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-16

No results posted yet for this study

Summary

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.

Conditions

  • Pouch, Ileal
  • Fistula

Interventions

DRUG

Ossium vBM-MSC

Vertebral bone marrow derived mesenchymal stem cells

OTHER

Placebo

Normal Saline

Sponsors & Collaborators

  • Ossium Health, Inc.

    collaborator INDUSTRY

  • Anthony Lembo

    lead OTHER

Principal Investigators

  • Amy Lightner, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-11-15
Completion
2024-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05075811 on ClinicalTrials.gov