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Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

Sponsor
Mesoblast, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01233960
Collaborator
(none)
73
Enrollment
20
Locations
1
Arm
45.5
Actual Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol 603 to evaluate the safety in subjects with active Crohn's disease who are resistant to standard Crohn's disease therapies.

Condition or Disease Intervention/Treatment Phase
  • Drug: adult human mesenchymal stem cells
 Phase 3

Detailed Description

Subjects will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As subjects will be required to be in Protocol 603 during the entire duration of their participation in Protocol 611, all concomitant medication and safety information will be monitored by Protocol 603 and the combination of data from the two protocols

Study Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's Disease
Actual Study Start Date :
Nov 29, 2010
Actual Primary Completion Date :
Sep 15, 2014
Actual Study Completion Date :
Sep 15, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prochymal

Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells.

Drug: adult human mesenchymal stem cells
PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.
Other Names:
  • Prochymal
  • remestemcel-L

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease remission [180 Days after first infusion in Protocol 603]

      Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ

    Secondary Outcome Measures

    1. Disease Improvement [180 Days after first infusion in Protocol 603]

      CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points.

    2. Improvement in Quality of Life (IBDQ) [180 Days after first infusion in Protocol 603]

      IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.

    3. Number of Adverse events as a measure of safety [180 Days after first infusion in Protocol 603]

    4. Infusional toxicity as a measure of safety and tolerability [180 Days after first infusion in Protocol 603]

      Infusional toxicity will be evaluated by continuously monitoring the subject's vital signs and O2 saturation by pulse oximetry from the time of PROCHYMAL administration until two hours after infusion is complete.

    Eligibility Criteria

    Criteria

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

    • Subject must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010.

    • Subject successfully completed all screening assessments in Protocol 603 as required by Protocol 603.

    • Subject successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010.

    • Subject must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.

    • Subject must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.

    Exclusion Criteria:

    • Subject is unwilling or unable to adhere to requirements of Protocol 611.

    • Subject had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.

    • Subject had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94115
    2 Clinical Research of West Florida Clearwater Florida United States 33765
    3 Shafran Gastroenterology Center Winter Park Florida United States 32789
    4 University of Chicago Chicago Illinois United States 60611
    5 Cotton-O'Neil Clinical Research Center Topeka Kansas United States 66606
    6 University of Maryland, Baltimore Baltimore Maryland United States 21201
    7 Chevy Chase Clinical Research Chevy Chase Maryland United States 20815
    8 Saint Louis Center for Clinical Research Saint Louis Missouri United States 63128
    9 St. Louis Center for Clinical Studies Saint Louis Missouri United States 63128
    10 Dartmouth HItchcock Medical Center Lebanon New Hampshire United States 03756
    11 Weill Cornell Medical College New York New York United States 10028
    12 Mount Sinai School of Medicine New York New York United States 10029
    13 Gastroenterology Center of the Midsouth, PC Germantown Tennessee United States 38138
    14 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    15 Baylor University Medical Center Dallas Texas United States 75246
    16 McGuire Research Institute Richmond Virginia United States 23249
    17 Royal Adelaide Hospital Adelaide South Australia Australia
    18 Royal Melbourne Hospital Melbourne Victoria Australia
    19 University of Otago Christchurch New Zealand
    20 Waikato Hospital Hamilton New Zealand

    Sponsors and Collaborators

    • Mesoblast, Inc.

    Investigators

    • Study Director: Mahboob Rahman, Mesoblast, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mesoblast, Inc.
    ClinicalTrials.gov Identifier:
    NCT01233960
    Other Study ID Numbers:
    • CRD 611
    First Posted:
    Nov 3, 2010
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mesoblast, Inc.
    Crohn's Disease
    Adult Stem Cell Therapy
    inflammation of the gastrointestinal tract
    Additional relevant MeSH terms:
    Crohn Disease
    Remestemcel-l

    Study Results

    No Results Posted as of Dec 8, 2021