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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01233960




Registration number
NCT01233960
Ethics application status
Date submitted
2/11/2010
Date registered
3/11/2010
Date last updated
8/12/2021

Titles & IDs
Public title
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
CRD 611
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - adult human mesenchymal stem cells

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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease remission
Timepoint [1] 0 0
180 Days after first infusion in Protocol 603
Secondary outcome [1] 0 0
Disease Improvement
Timepoint [1] 0 0
180 Days after first infusion in Protocol 603
Secondary outcome [2] 0 0
Improvement in Quality of Life (IBDQ)
Timepoint [2] 0 0
180 Days after first infusion in Protocol 603
Secondary outcome [3] 0 0
Number of Adverse events as a measure of safety
Timepoint [3] 0 0
180 Days after first infusion in Protocol 603
Secondary outcome [4] 0 0
Infusional toxicity as a measure of safety and tolerability
Timepoint [4] 0 0
180 Days after first infusion in Protocol 603

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/09/2014
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Hampshire
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
New Zealand
State/province [12] 0 0
Christchurch
Country [13] 0 0
New Zealand
State/province [13] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mesoblast, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01233960
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mahboob Rahman
Address 0 0
Mesoblast, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01233960