Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02293603
Status:
UNKNOWN
Last Update Posted:
2016-06-21
First Post:
2014-11-05
Brief Title:
Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells DYNAMIC
Sponsor:
Capricor Inc
Organization:
Capricor Inc
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase I Study of the Safety of Multi-vessel Intra-coronary Delivery of Allogeneic Human Cardiosphere-Derived Stem Cells in Patients With Dilated Cardiomyopathy DCM
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
DYNAMIC
Brief Summary:
To determine the safety profile of CAP-1002 administered by multi-vessel intracoronary infusion in subjects with DCM The study will further explore safety and exploratory efficacy endpoints of CAP-1002
Detailed Description:
Eligible subjects will undergo sequential intracoronary infusion of CAP-1002 or placebo in up to three coronary arteries supplying three major cardiac territories to the heart anterior lateral inferiorposterior After completion of the screening procedures Phase Ia subjects will receive CAP-1002 administered via intracoronary infusion in a dose escalation stepwise manner Phase Ia subjects will be followed at Week 2 and at Months 1 2 3 6 and 12 after CAP-1002 infusion The first fourteen 14 subjects will receive intracoronary infusion of CAP-1002 in an open-label fashion Phase Ia Once all 14 subjects in the Phase Ia have reached the primary safety endpoint 1 month visit the DSMB will conduct a review of the Phase Ia data and recommend whether to proceed with enrollment of the next 28 subjects in the Phase Ib
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44HL095203 | NIH | None | httpsreporternihgovquickSearchR44HL095203 |