Clinical Readiness Skin Punch Biopsy Sample Collections

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
HeartWorks, Inc.
Study ID
NCT06588426
Status
Recruiting
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Conditions

  • Congenital Heart Defect
  • Congenital Heart Disease (CHD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.

Key Dates

Start date
Sep 13, 2024
Status verified
Jun 2025
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Participants with congenital heart disease

Primary Outcome Measure

Successful manufacture of induced pluripotent stem cells [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Karen Miller
[email protected]
507-266-6459
Lori Riess
[email protected]
507-266-6459
Rebecca K Ameduri, M.D. (PRINCIPAL_INVESTIGATOR)

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