Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

March 6, 2020 updated by: Mesoblast, Inc.

An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL.

The study is not placebo-controlled or randomized.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Unviersity of California, San Francisco
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Stormont-Vail
    • New York
      • New York, New York, United States, 10128
        • Mount Sinai Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2285
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • currently active moderate-to-severe Crohn's disease
  • exhausted standard-of-care options
  • age 18 to 70 inclusive
  • body weight between 30 and 150 kg
  • adequate renal function
  • not at risk for tuberculosis (TB) activation or re-activation

Exclusion Criteria:

  • biologic therapy for Crohn's within last 8 weeks
  • confirmed adverse reactions during prior PROCHYMAL study participation
  • alcohol or substance abuse, current or within past 6 months
  • active HIV or hepatitis B or C infection
  • surgery or trauma with 6 weeks
  • allergy to bovine or porcine products
  • elevated serum liver enzymes
  • elevated serum bilirubin
  • active malignancy within 5 years (other than some resected skin cancers)
  • bacteremia or other serious bacterial or fungal infection within 3 months
  • colonic dysplasia
  • unstable arrhythmia or serious heart condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mesoblast, Inc.

Investigators

  • Study Director: Mahboob Rahman, MD, Mesoblast, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 16, 2012

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD 620

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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