Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells in Chronic Ischemic Cardiomyopathy: A Controlled, Randomized Clinical Trial (HUC-HEART Trial).
Bone marrow MSC
Clinical trial
Ischemic cardiomyopathy
Stem cell therapy
Umbilical cord MSC
Journal
International journal of stem cells
ISSN: 2005-3606
Titre abrégé: Int J Stem Cells
Pays: Korea (South)
ID NLM: 101497587
Informations de publication
Date de publication:
30 Nov 2020
30 Nov 2020
Historique:
received:
04
05
2020
revised:
18
06
2020
accepted:
06
07
2020
pubmed:
26
8
2020
medline:
26
8
2020
entrez:
26
8
2020
Statut:
ppublish
Résumé
The HUC-HEART Trial (ClinicalTrials.gov Identifier: NCT02323477) was a controlled, prospective, phase I/II, multicenter, single-blind, three-arm randomized study of intramyocardial delivery of human umbilical cord-derived mesenchymal stromal cells (HUC-MSCs) combined with coronary artery bypass-grafting (CABG) in patients with chronic ischemic cardiomyopathy (CIC). The trial aimed to assess (i) the safety and the efficacy of cell transplantation during one-year follow-up, (ii) to compare the efficacy of HUC-MSCs with autologous bone-marrow- derived mononuclear cells (BM-MNCs) in the same clinical settings. Fifty-four patients who were randomized to receive HUC-MSCs (23×10 Significant findings directly related to the intramyocardial delivery of HUC-MSCs justified their efficacy in CIC. Stricter patient selection criteria with precisely aligned cell dose and delivery intervals, rigorous follow-up by detailed diagnostic approaches would further help to clarify the responsiveness to the therapy.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
The HUC-HEART Trial (ClinicalTrials.gov Identifier: NCT02323477) was a controlled, prospective, phase I/II, multicenter, single-blind, three-arm randomized study of intramyocardial delivery of human umbilical cord-derived mesenchymal stromal cells (HUC-MSCs) combined with coronary artery bypass-grafting (CABG) in patients with chronic ischemic cardiomyopathy (CIC). The trial aimed to assess (i) the safety and the efficacy of cell transplantation during one-year follow-up, (ii) to compare the efficacy of HUC-MSCs with autologous bone-marrow- derived mononuclear cells (BM-MNCs) in the same clinical settings.
METHODS AND RESULTS
RESULTS
Fifty-four patients who were randomized to receive HUC-MSCs (23×10
CONCLUSIONS
CONCLUSIONS
Significant findings directly related to the intramyocardial delivery of HUC-MSCs justified their efficacy in CIC. Stricter patient selection criteria with precisely aligned cell dose and delivery intervals, rigorous follow-up by detailed diagnostic approaches would further help to clarify the responsiveness to the therapy.
Identifiants
pubmed: 32840230
pii: ijsc20075
doi: 10.15283/ijsc20075
pmc: PMC7691850
doi:
Banques de données
ClinicalTrials.gov
['NCT02323477']
Types de publication
Journal Article
Langues
eng
Pagination
364-376Références
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