|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
4 January 2022 |
|
Main ID: |
NCT00543374 |
|
Date of registration:
|
11/10/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
|
|
Scientific 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 |
|
Date of first enrolment:
|
September 17, 2007 |
|
Target sample size:
|
98 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00543374 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Canada
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Mahboob Rahman, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mesoblast, Inc. |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Crohn's Disease
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: PROCHYMAL adult human mesenchymal stem cells
|
|
Primary Outcome(s)
|
|
Re-induction of clinical benefit (Crohn's disease activity index)
[Time Frame: 6 months]
|
|
Duration of clinical benefit (Crohn's disease activity index)
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument)
[Time Frame: 6 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|