Clinical Readiness Skin Punch Biopsy Sample Collections

NCT ID: NCT06588426

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-13

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Congenital Heart Disease (CHD) Congenital Heart Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with congenital heart disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 18 and older
* Congenital heart disease
* Likely to qualify for an active clinical trial under IND 28611 in the future

Exclusion Criteria

* Previous cardiac transplantation
* Unable or unwilling to consent
* HIV diagnosis
* Hepatitis diagnosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HeartWorks, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Armstrong

Role: CONTACT

(507) 577-1764

Facility Contacts

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Karen Miller

Role: primary

507-266-6459

Lori Riess

Role: backup

507-266-6459

Related Links

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Other Identifiers

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IPSC-CL-002

Identifier Type: -

Identifier Source: org_study_id

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