Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02485938
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2015-06-19
Brief Title:
HOPE-Duchenne Halt cardiomyOPathy progrEssion in Duchenne
Sponsor:
Capricor Inc
Organization:
Capricor Inc
Study Overview
Official Title:
A Randomized Open-label Study of the Safety and Efficacy of Multi- Vessel Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With Cardiomyopathy Secondary to Duchenne Muscular Dystrophy
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOPE
Brief Summary:
Male subjects with cardiomyopathy secondary to Duchenne muscular dystrophy DMD meeting all inclusion and no exclusion criteria will be randomized All subjects will be at least 12 years of age They will be randomized in a 11 manner to either intracoronary infusion of CAP-1002 in three coronary arteries supplying the three major cardiac territories of the left ventricle of the heart anterior lateral inferiorposterior or usual care In the active treatment arm all three major cardiac territories will be treated infused during a single procedure in an open-label fashion
Detailed Description:
Approximately 24 and not more than 30 subjects will be randomized into the study in two sequential enrollment groups Safety data from Group 1 will undergo a Data Safety Monitoring Board DSMB review prior to initiation of enrollment for Group 2
The first 6-8 randomized subjects will comprise Group 1 and will include a minimum of 3 subjects completing intracoronary infusion with CAP-1002 The DSMB will conduct a review of interim safety data through 72 hours post-Day 0 for at least 3 infused subjects and for at least 6 subjects overall
Enrollment of Group 2 will begin per DSMB recommendations following their review of the 72 hour safety data from Group 1 Group 2 will include approximately 18 subjects Screening and randomization will continue until at total of 12 subjects are infused with CAP 1002 or 30 subjects are randomized into the study whichever comes first
All subjects assigned to the active treatment arm will receive an intended total dose of up to 75 million M CAP-1002 cells infused as 25M cells into each of the three left ventricle cardiac territories anterior lateral inferiorposterior
Subjects randomized to receive usual care will continue to be cared for and treated in whatever manner the investigator deems most appropriate for the subject on an ongoing basis and will receive no infusion
Randomization will take place within 30 days of the first screening procedure After completion of the screening procedures eligible subjects randomized to active treatment arm will receive CAP-1002 administered via intracoronary infusion on Day 0 Day 0 for eligible subjects randomized to the usual care arm will occur 7 days after the date of randomization All randomized subjects will have a follow-up telephone call on Study Day 3 and study visits at Weeks 2 and 6 and at Months 3 6 and 12 post Day 0
The first 6-8 randomized subjects will comprise Group 1 and will include a minimum of 3 subjects completing intracoronary infusion with CAP-1002 The DSMB will conduct a review of interim safety data through 72 hours post-Day 0 for at least 3 infused subjects and for at least 6 subjects overall
Enrollment of Group 2 will begin per DSMB recommendations following their review of the 72 hour safety data from Group 1 Group 2 will include approximately 18 subjects Screening and randomization will continue until at total of 12 subjects are infused with CAP 1002 or 30 subjects are randomized into the study whichever comes first
All subjects assigned to the active treatment arm will receive an intended total dose of up to 75 million M CAP-1002 cells infused as 25M cells into each of the three left ventricle cardiac territories anterior lateral inferiorposterior
Subjects randomized to receive usual care will continue to be cared for and treated in whatever manner the investigator deems most appropriate for the subject on an ongoing basis and will receive no infusion
Randomization will take place within 30 days of the first screening procedure After completion of the screening procedures eligible subjects randomized to active treatment arm will receive CAP-1002 administered via intracoronary infusion on Day 0 Day 0 for eligible subjects randomized to the usual care arm will occur 7 days after the date of randomization All randomized subjects will have a follow-up telephone call on Study Day 3 and study visits at Weeks 2 and 6 and at Months 3 6 and 12 post Day 0
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None