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Trial record 1 of 1 for:    NCT00543374
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Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease

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ClinicalTrials.gov Identifier: NCT00543374
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Brief Summary:
Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Placebo Drug: PROCHYMAL adult human mesenchymal stem cells Phase 3

Detailed Description:

A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.

PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.

Protocol 610 is an extension study offered only to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease
Actual Study Start Date : September 17, 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : April 28, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

Active Comparator: PROCHYMAL Low dose
Low dose (total of 600 million cells)
Drug: PROCHYMAL adult human mesenchymal stem cells
intravenous infusion four times over two weeks; possibly repeated once

Active Comparator: PROCHYMAL High dose
High dose (total of 1200 cells)
Drug: PROCHYMAL adult human mesenchymal stem cells
intravenous infusion four times over two weeks; possibly repeated once




Primary Outcome Measures :
  1. Duration of clinical benefit (Crohn's disease activity index) [ Time Frame: 6 months ]
  2. Re-induction of clinical benefit (Crohn's disease activity index) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28

Exclusion Criteria:

  • Substance abuse
  • Failure to receive full dose of all interventions in Protocol 603

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543374


Locations
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Sponsors and Collaborators
Mesoblast, Inc.
Investigators
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Study Director: Mahboob Rahman, MD Mesoblast, Inc.
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Responsible Party: Mesoblast, Inc.
ClinicalTrials.gov Identifier: NCT00543374    
Other Study ID Numbers: CRD 610
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Remestemcel-l
Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents