Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

NCT01233960 | Completed Phase 3 FDA Drug

• 1 other identifier: CRD 611
• Study Type: interventional
• Target: 73
• Locations: 3 countries
• Sites: 20

Brief Summary

To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Adult Stem Cell Therapy; inflammation of the gastrointestinal tract

Outcome Measures

Primary Outcomes (1)

• Disease remission

  Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ

  180 Days after first infusion in Protocol 603

Secondary Outcomes (4)

• Disease Improvement

  180 Days after first infusion in Protocol 603

• Improvement in Quality of Life (IBDQ)

  180 Days after first infusion in Protocol 603

• Number of Adverse events as a measure of safety

  180 Days after first infusion in Protocol 603

• Infusional toxicity as a measure of safety and tolerability

  180 Days after first infusion in Protocol 603

Study Arms (1)

Prochymal®

EXPERIMENTAL

Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells.

Drug: Prochymal®

Interventions

Prochymal® DRUG

PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.

Also known as: Adult human mesenchymal stem cells, Remestemcel-L

Prochymal®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010.
• Participant successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
• Participant successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010.
• Participant must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
• Participant must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.

You may not qualify if:

• Participant is unwilling or unable to adhere to requirements of Protocol 611.
• Participant had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
• Participant had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.

Sponsors & Collaborators

• Mesoblast, Inc.: lead

Study Sites (20)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

University of Chicago

Chicago, Illinois, 60611, United States

Location

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Saint Louis Center for Clinical Research

St Louis, Missouri, 63128, United States

Location

St. Louis Center for Clinical Studies

St Louis, Missouri, 63128, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Weill Cornell Medical College

New York, New York, 10028, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Gastroenterology Center of the Midsouth, PC

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

McGuire Research Institute

Richmond, Virginia, 23249, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Location

University of Otago

Christchurch, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

remestemcel-l

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Christopher James, PA

  Mesoblast, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 3, 2010
• Study Start: November 29, 2010
• Primary Completion: September 15, 2014
• Study Completion: September 15, 2014
• Last Updated: March 11, 2026

Record last verified: 2025-11

Locations

NZ (2); AU (2); US (16)