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Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease

NCT00543374 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-03-11

No results posted yet for this study

Summary

Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.

Conditions

Interventions

DRUG

Placebo

DRUG

PROCHYMAL adult human mesenchymal stem cells

intravenous infusion four times over two weeks; possibly repeated once

Sponsors & Collaborators

  • Mesoblast, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher James, PA · 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
2009-07-31
Completion
2011-04-28
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT00543374 on ClinicalTrials.gov