Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT03071835
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2017-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study of Subjects Past Their Final Follow-ON Visit
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)
Status:
COMPLETED
Status Verified Date:
2023-10
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:
HYPERION
Brief Summary:
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
Detailed Description:
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
Subjects will be followed during the study depending on the initial visit for this trial. The time point at which they are followed will depend on the subject's injection date in the previous trial. Depending on the subjects first treatment date (Day of injection) in the previous Interdisciplinary Stem Cell Institute (ISCI) cardiovascular clinical trial, subjects may be eligible for one to four study visits in this trial. Those who do not have a three, five, seven, nine or eleven year visit may receive informed consent at the year thirteen visit. Thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed.
Subjects will be followed during the study depending on the initial visit for this trial. The time point at which they are followed will depend on the subject's injection date in the previous trial. Depending on the subjects first treatment date (Day of injection) in the previous Interdisciplinary Stem Cell Institute (ISCI) cardiovascular clinical trial, subjects may be eligible for one to four study visits in this trial. Those who do not have a three, five, seven, nine or eleven year visit may receive informed consent at the year thirteen visit. Thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: