Clinical Readiness Skin Punch Biopsy Sample Collections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeartWorks, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 and older
Congenital heart disease
Likely to qualify for an active clinical trial under IND 28611 in the future
Disqualifiers
Previous cardiac transplantation
Unable or unwilling to consent
HIV diagnosis
Hepatitis diagnosis
Trial population
Congenital heart disease patients likely to qualify in the future for treatment using iPSC-CL in an approved clinical trial under IND 28611
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Participants with congenital heart disease
Trial outcomes
Primary outcomes
1
Successful manufacture of induced pluripotent stem cells
Outcome measured will be the manufacture of iPSC that meets pre-determined acceptance criteria.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov