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A Comparative Study of Subjects Past Their Final Follow-ON Visit (HYPERION)

University of Miami logo

University of Miami

Status

Completed

Conditions

Aging Frailty
Heart Diseases
Cardiomyopathies

Study type

Observational

Funder types

Other

Identifiers

NCT03071835
20150899

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Be 18 years of age and older
  • Provide written informed consent
  • Have been previously enrolled or currently participating in an investigator-initiated cardiovascular trial at ISCI (In cases where participants are currently enrolled in another clinical trial they are still able to participate concurrently in this trial).

Exclusion criteria

  • Have known, serious radiographic contrast allergy, which cannot be managed with premedication only if able to undergo MRI or CT.
  • Have a history of drug or alcohol abuse within the past 24 months

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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