PMID- 36226504
OWN - NLM
STAT- MEDLINE
DCOM- 20221021
LR  - 20221104
IS  - 1746-076X (Electronic)
IS  - 1746-0751 (Linking)
VI  - 17
IP  - 12
DP  - 2022 Dec
TI  - Cell administration routes for heart failure: a comparative re-evaluation of the 
      REGENERATE-DCM and REGENERATE-IHD trials.
PG  - 891-903
LID - 10.2217/rme-2022-0138 [doi]
AB  - Aims: Given the logistical issues surrounding intramyocardial cell delivery, we 
      sought to address the efficacy of the simpler, more accessible intracoronary 
      route by re-evaluating REGENERATE-DCM and REGENERATE-IHD (autologous cell therapy 
      trials for heart failure; n = 150). Methods: A retrospective statistical analysis 
      was performed on the trials' combined data. The following end points were 
      evaluated: left ventricular ejection fraction (LVEF), N-terminal pro brain 
      natriuretic peptide concentration (NT-proBNP), New York Heart Association class 
      (NYHA) and quality of life. Results: This demonstrated a new efficacy signal for 
      intracoronary delivery, with significant benefits to: LVEF (3.7%; p = 0.01), 
      NT-proBNP (median -76 pg/ml; p = 0.04), NYHA class (48% patients; p = 0.01) and 
      quality of life (12 +/- 19; p = 0.006). The improvements in LVEF, NYHA and quality 
      of life scores remained significant compared to the control group. Conclusion: 
      The efficacy and logistical simplicity of intracoronary delivery should be taken 
      into consideration for future trials.
FAU - Sim, Doo Sun
AU  - Sim DS
AD  - Centre for Cardiovascular Medicine & Devices, William Harvey Research Institute, 
      Queen Mary University of London, London, UK.
AD  - Department of Cardiovascular Medicine, Chonnam National University Hospital, 
      Chonnam National University School of Medicine, Gwanjgu, Republic of Korea.
FAU - Jones, Daniel A
AU  - Jones DA
AD  - Centre for Cardiovascular Medicine & Devices, William Harvey Research Institute, 
      Queen Mary University of London, London, UK.
AD  - Department of Interventional Cardiology, Barts Heart Centre, Barts Health NHS 
      Trust, London, UK.
FAU - Davies, Ceri
AU  - Davies C
AD  - Centre for Cardiovascular Medicine & Devices, William Harvey Research Institute, 
      Queen Mary University of London, London, UK.
AD  - Department of Interventional Cardiology, Barts Heart Centre, Barts Health NHS 
      Trust, London, UK.
FAU - Locca, Didier
AU  - Locca D
AD  - Centre for Cardiovascular Medicine & Devices, William Harvey Research Institute, 
      Queen Mary University of London, London, UK.
AD  - Ecole Polytechnique Federale de Lausanne, Lausanne, Switzerland.
FAU - Veerapen, Jessry
AU  - Veerapen J
AD  - Centre for Cardiovascular Medicine & Devices, William Harvey Research Institute, 
      Queen Mary University of London, London, UK.
AD  - Department of Interventional Cardiology, Barts Heart Centre, Barts Health NHS 
      Trust, London, UK.
FAU - Reid, Alice
AU  - Reid A
AD  - Centre for Cardiovascular Medicine & Devices, William Harvey Research Institute, 
      Queen Mary University of London, London, UK.
FAU - Godec, Thomas
AU  - Godec T
AD  - Centre for Cardiovascular Medicine & Devices, William Harvey Research Institute, 
      Queen Mary University of London, London, UK.
AD  - Barts Cardiovascular Clinical Trials Unit, William Harvey Research Institute, 
      Queen Mary University of London, London, UK.
FAU - Martin, John
AU  - Martin J
AD  - University College London, London, UK.
FAU - Mathur, Anthony
AU  - Mathur A
AUID- ORCID: 0000-0001-7941-9653
AD  - Centre for Cardiovascular Medicine & Devices, William Harvey Research Institute, 
      Queen Mary University of London, London, UK.
AD  - Department of Interventional Cardiology, Barts Heart Centre, Barts Health NHS 
      Trust, London, UK.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221013
PL  - England
TA  - Regen Med
JT  - Regenerative medicine
JID - 101278116
SB  - IM
MH  - Humans
MH  - Stroke Volume
MH  - *Ventricular Function, Left
MH  - Quality of Life
MH  - Retrospective Studies
MH  - *Heart Failure/therapy
OAB - Trials of cell therapy for heart failure have not clearly identified the best 
      method to deliver the cells to the heart. A small proportion of these studies 
      have used the intracoronary method (which infuses the cells into the heart's 
      arteries) as it was thought to be less effective. However, this is the simplest 
      method and uses widely accessible techniques and equipment. By combining data 
      from two previous heart failure trials, we sought to look for an efficacy signal 
      for the intracoronary method in a larger sample size. We found that the 
      intracoronary route demonstrated improvements in patients' heart function and 
      symptoms. Although it may require a larger number of patients to show efficacy, 
      this signal, alongside the intracoronary route's relative simplicity, should be 
      taken into consideration when future trials of cell therapy for heart failure are 
      planned.
OABL- eng
OTO - NOTNLM
OT  - adult stem cells
OT  - cardiology
OT  - cell therapy
OT  - clinical trial
OT  - heart failure
OT  - repair
OT  - stem cells
EDAT- 2022/10/14 06:00
MHDA- 2022/10/22 06:00
CRDT- 2022/10/13 04:02
PHST- 2022/10/14 06:00 [pubmed]
PHST- 2022/10/22 06:00 [medline]
PHST- 2022/10/13 04:02 [entrez]
AID - 10.2217/rme-2022-0138 [doi]
PST - ppublish
SO  - Regen Med. 2022 Dec;17(12):891-903. doi: 10.2217/rme-2022-0138. Epub 2022 Oct 13.