Congenital Heart Disease (CHD)NCT06588426
Clinical Readiness Skin Punch Biopsy Sample Collections
An observational study of Congenital Heart Disease (CHD) and Congenital Heart Defect, run by HeartWorks, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease (CHD), Congenital Heart Defect
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2024to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age 18 and older
- Congenital heart disease
- Likely to qualify for an active clinical trial under IND 28611 in the future
Who cannot join
- Previous cardiac transplantation
- Unable or unwilling to consent
- HIV diagnosis
- Hepatitis diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Karen Miller, 507-266-6459, HLHS@mayo.edu
Lori Riess, 507-266-6459, HLHS@mayo.edu
About this study
Official title: Clinical Readiness Skin Punch Biopsy Sample Collection
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.
Read the detailed description
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.
- Keywords
- CHD, Congenital Heart Defect
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with congenital heart disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful manufacture of induced pluripotent stem cells
Outcome measured will be the manufacture of iPSC that meets pre-determined acceptance criteria.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start13 Sep 2024
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeartWorks, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588426
- Sponsor's protocol ID
- IPSC-CL-002
- Status last verified
- Jun 2025
- First submitted
- 6 Sep 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Readiness Skin Punch Biopsy Sample Collection
- ClinicalTrials.gov ID
- NCT06588426
- Acronym / sponsor ID
- IPSC-CL-002
- Keywords
- CHD, Congenital Heart Defect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HeartWorks, Inc.University, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with congenital heart disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Age 18 and older
- Congenital heart disease
- Likely to qualify for an active clinical trial under IND 28611 in the future
Key exclusion criteria (4 listed)
- Previous cardiac transplantation
- Unable or unwilling to consent
- HIV diagnosis
- Hepatitis diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful manufacture of induced pluripotent stem cells
Time frame: 12 months
Outcome measured will be the manufacture of iPSC that meets pre-determined acceptance criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- General trial informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease (CHD) and Congenital Heart Defect, run by HeartWorks, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Armstrong ((507) 577-1764, clinical@webuildhearts.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful manufacture of induced pluripotent stem cells (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.