PMID- 32840230
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220418
IS  - 2005-3606 (Print)
IS  - 2005-5447 (Electronic)
IS  - 2005-3606 (Linking)
VI  - 13
IP  - 3
DP  - 2020 Nov 30
TI  - Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells in 
      Chronic Ischemic Cardiomyopathy: A Controlled, Randomized Clinical Trial 
      (HUC-HEART Trial).
PG  - 364-376
LID - 10.15283/ijsc20075 [doi]
AB  - BACKGROUND AND OBJECTIVES: 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: Fifty-four patients who were 
      randomized to receive HUC-MSCs (23x10(6)) (n=26) or BM-MNCs (70x10(7)) (n=12) in 
      combination with CABG surgery. The control patients (n=16) received no 
      cells/vehicles but CABG intervention. All patients were screened at baseline and 
      1, 3, 6, 12 months after transplantation. Forty-six (85%) patients completed 12 
      months follow-up. No short/mid-term adverse events were encountered. Decline in 
      NT-proBNP (baseline approximately  6 months) in both cell-treated groups; an increase in left 
      ventricular ejection fraction (LVEF) (5.4%) and stroke volume (19.7%) were noted 
      (baseline approximately 6 or 12 months) only in the HUC-MSC group. Decreases were also detected 
      in necrotic myocardium as 2.3% in the control, 4.5% in BM-MNC, and 7.7% in the 
      HUC-MSC groups. The 6-min walking test revealed an increase in the control 
      (14.4%) and HUC-MSC (23.1%) groups. 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.
FAU - Ulus, A Tulga
AU  - Ulus AT
AD  - Department of Cardiovascular Surgery, Hacettepe University Faculty of Medicine, 
      Ankara, Turkey.
FAU - Mungan, Ceren
AU  - Mungan C
AD  - Ankara University Biotechnology Institute and Sisbiyotek, Ankara, Turkey.
FAU - Kurtoglu, Murat
AU  - Kurtoglu M
AD  - Cardiovascular Surgery Division, Ankara Guven Hospital, Ankara, Turkey.
FAU - Celikkan, Ferda Topal
AU  - Celikkan FT
AD  - Department of Histology and Embryology, Laboratory for Stem Cells and 
      Reproductive Cell Biology, Ankara University School of Medicine, Ankara, Turkey.
FAU - Akyol, Mesut
AU  - Akyol M
AD  - Department of Biostatistics, Ankara Yildirim Beyazit University, Ankara, Turkey.
FAU - Sucu, Merve
AU  - Sucu M
AD  - Ankara University Biotechnology Institute and Sisbiyotek, Ankara, Turkey.
FAU - Toru, Mustafa
AU  - Toru M
AD  - Radiology Division, Ankara Liv Hospital, Ankara, Turkey.
FAU - Gul, Serdar Savas
AU  - Gul SS
AD  - Visart Medical Imaging Center, Ankara, Turkey.
FAU - Cinar, Ozgur
AU  - Cinar O
AD  - Department of Histology and Embryology, Laboratory for Stem Cells and 
      Reproductive Cell Biology, Ankara University School of Medicine, Ankara, Turkey.
FAU - Can, Alp
AU  - Can A
AD  - Department of Histology and Embryology, Laboratory for Stem Cells and 
      Reproductive Cell Biology, Ankara University School of Medicine, Ankara, Turkey.
LA  - eng
SI  - ClinicalTrials.gov/NCT02323477
PT  - Journal Article
PL  - Korea (South)
TA  - Int J Stem Cells
JT  - International journal of stem cells
JID - 101497587
PMC - PMC7691850
OTO - NOTNLM
OT  - Bone marrow MSC
OT  - Clinical trial
OT  - Ischemic cardiomyopathy
OT  - Stem cell therapy
OT  - Umbilical cord MSC
COIS- Potential Conflict of Interest The authors have no conflicting financial 
      interest.
EDAT- 2020/08/26 06:00
MHDA- 2020/08/26 06:01
PMCR- 2020/08/31
CRDT- 2020/08/26 06:00
PHST- 2020/05/04 00:00 [received]
PHST- 2020/06/18 00:00 [revised]
PHST- 2020/07/06 00:00 [accepted]
PHST- 2020/08/26 06:00 [pubmed]
PHST- 2020/08/26 06:01 [medline]
PHST- 2020/08/26 06:00 [entrez]
PHST- 2020/08/31 00:00 [pmc-release]
AID - ijsc20075 [pii]
AID - IJSC-13-364 [pii]
AID - 10.15283/ijsc20075 [doi]
PST - ppublish
SO  - Int J Stem Cells. 2020 Nov 30;13(3):364-376. doi: 10.15283/ijsc20075.