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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
ClinicalTrials.gov Identifier:
NCT01510431
First received: January 9, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention
Crohn's Disease
Drug: PROCHYMAL (remestemcel-L)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • Crohn's disease activity index (CDAI) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Look for decrease in CDAI at 1 month


Estimated Enrollment: 10
Study Start Date: May 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROCHYMAL
Mesenchymal stem cells
Drug: PROCHYMAL (remestemcel-L)
intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510431

Locations
United States, California
Unviersity of California, San Francisco
San Francisco, California, United States, 94115
United States, Kansas
Stormont-Vail
Topeka, Kansas, United States, 66606
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10128
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2285
Sponsors and Collaborators
Mesoblast International Sàrl
  More Information

No publications provided

Responsible Party: Mesoblast, Ltd. ( Mesoblast International Sàrl )
ClinicalTrials.gov Identifier: NCT01510431     History of Changes
Other Study ID Numbers: CRD 620
Study First Received: January 9, 2012
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 27, 2014