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Mesenchymal Stem Cells (MSCs) for Perianal Fistula

NCT05407766 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-12-23

No results posted yet for this study

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

BIOLOGICAL

OSSM-001

Single injection of OSSM-001 at dose of 100M or 300M cells

OTHER

Placebo

Single injection of placebo (saline)

Sponsors & Collaborators

  • Ossium Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Sagar Munjal, MD · Ossium Health, Inc.

  • Amy Lightner, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2024-04-30
Completion
2024-08-31
FDA Drug
Yes

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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 NCT05407766 on ClinicalTrials.gov