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Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP)

Study acronym: MedCaP
StatusActive, Not Recruiting
PhasePhase 1
Started2020-07-29
View on ClinicalTrials.gov ↗
The proposed study will be a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life

Amendment record

Amended 8 times since 2020-01-17; most recent filed 2026-05-29. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-05-29
Amendment Study Identification, Study Status, Oversight, Eligibility, IPDSharing v8
2025-04-27
Amendment Study Status, Oversight, IPDSharing v7
2023-09-19
Amendment Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v6
2022-05-11
Amendment Study Status v5
2021-04-01
Amendment Study Status v4
2021-02-23
Amendment Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v3
2020-07-10
Amendment Study Status v2
2020-03-18
Amendment Study Status v1
2020-01-17
Original filing
Trial Details
NCT Number NCT04236479
Lead Sponsor Catherine Bollard
Conditions Congenital Heart Disease (CHD)
Enrollment 17 participants
Start Date 2020-07-29
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-02