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Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

NCT00482092 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-03-11

No results posted yet for this study

Summary

Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.

Conditions

Interventions

DRUG

Prochymal®

Prochymal® IV infusion

DRUG

Placebo

Prochymal® Placebo-matching IV infusion

Sponsors & Collaborators

  • Mesoblast, Inc.

    lead INDUSTRY

Principal Investigators

  • Mahboob Rahman, MD · Mesoblast, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-17
Primary Completion
2014-09-15
Completion
2014-09-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00482092 on ClinicalTrials.gov