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

Primary Purpose

Crohn's Disease

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
PROCHYMAL (remestemcel-L)
Sponsored by
Mesoblast, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Crohn's Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unviersity of California, San Francisco
  • Stormont-Vail
  • Mount Sinai Hospital
  • Vanderbilt University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 9, 2012
Last Updated
March 6, 2020
Sponsor
Mesoblast, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01510431
Brief Title
Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
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
Study Type
Expanded Access

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mesoblast, Inc.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PROCHYMAL (remestemcel-L)
Intervention Description
intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahboob Rahman, MD
Organizational Affiliation
Mesoblast, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Unviersity of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stormont-Vail
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2285
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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