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Completed

NCT Number: NCT00543374

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.

PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.

Protocol 610 is an extension study offered only to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28

Exclusion criteria

  • Substance abuse
  • Failure to receive full dose of all interventions in Protocol 603

Treatment and study plan

Placebo

Drug

PROCHYMAL adult human mesenchymal stem cells

Drug

intravenous infusion four times over two weeks; possibly repeated once

Primary outcomes

  1. Duration of clinical benefit (Crohn's disease activity index)

    Time frame: 6 months

  2. Re-induction of clinical benefit (Crohn's disease activity index)

    Time frame: 6 months

Secondary outcomes

  1. Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mesoblast, Inc.

Industry

Registry information

Official study title

A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Oct 15, 2007
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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