NCT01510431

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

First QC Date

January 9, 2012

Last Update Submit

March 6, 2020

Conditions

Crohn's Disease

Interventions

PROCHYMAL (remestemcel-L)DRUG

intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unviersity of California, San Francisco

San Francisco, California, 94115, United States

Location

Stormont-Vail

Topeka, Kansas, 66606, United States

Location

Mount Sinai Hospital

New York, New York, 10128, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2285, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

remestemcel-l

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Mahboob Rahman, MD

    Mesoblast, Inc.

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 16, 2012

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

US(4)