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

Sponsor
Mesoblast, Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT01510431
Collaborator
(none)
4
Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PROCHYMAL (remestemcel-L)

Study Design

Study Type:
Expanded Access
Official Title:
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Unviersity of California, San Francisco San Francisco California United States 94115
    2 Stormont-Vail Topeka Kansas United States 66606
    3 Mount Sinai Hospital New York New York United States 10128
    4 Vanderbilt University Medical Center Nashville Tennessee United States 37232-2285

    Sponsors and Collaborators

    • Mesoblast, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mesoblast, Inc.
    ClinicalTrials.gov Identifier:
    NCT01510431
    Other Study ID Numbers:
    • CRD 620
    First Posted:
    Jan 16, 2012
    Last Update Posted:
    Mar 10, 2020
    Last Verified:
    Mar 1, 2020
    Additional relevant MeSH terms:
    Crohn Disease
    Remestemcel-l

    Study Results

    No Results Posted as of Mar 10, 2020