NCT06588426

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Sep 2024Jul 2027

First Submitted

Initial submission to the registry

September 6, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

September 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2.3 years

First QC Date

September 6, 2024

Last Update Submit

June 23, 2025

Conditions

Congenital Heart Disease (CHD)Congenital Heart Defect

Keywords

CHDCongenital Heart Defect

Outcome Measures

Primary Outcomes (1)

  • Successful manufacture of induced pluripotent stem cells

    Outcome measured will be the manufacture of iPSC that meets pre-determined acceptance criteria.

    12 months

Study Arms (1)

Participants with congenital heart disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Congenital heart disease patients likely to qualify in the future for treatment using iPSC-CL in an approved clinical trial under IND 28611

You may qualify if:

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

You may not qualify if:

  • Previous cardiac transplantation
  • Unable or unwilling to consent
  • HIV diagnosis
  • Hepatitis diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Sample will be manufactured into fibroblasts and induced pluripotent stem cells.

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Adam Armstrong

CONTACT

(507) 577-1764clinical@webuildhearts.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

September 13, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)