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The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina.

Publication ,  Journal Article
Povsic, TJ; Henry, TD; Traverse, JH; Fortuin, FD; Schaer, GL; Kereiakes, DJ; Schatz, RA; Zeiher, AM; White, CJ; Stewart, DJ; Jolicoeur, EM ...
Published in: JACC Cardiovasc Interv
August 8, 2016

OBJECTIVES: This study tested whether intramyocardial (IM) administration of mobilized, purified autologous CD34(+) cells would improve total exercise time (TET) and angina frequency in patients with refractory angina. BACKGROUND: IM administration of autologous CD34(+) cells has been associated consistently with improvements in functional capacity and angina symptoms in early phase clinical trials. METHODS: RENEW (Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina) was a randomized, double-blind, multicenter trial comparing IM CD34(+) administration with no intervention (open-label standard of care) or IM placebo injections (active control). The primary efficacy endpoint was change in TET at 12 months. Key secondary endpoints include changes in angina frequency at 3, 6, and 12 months, and TET at 3 and 6 months. The key safety analysis was the incidence of major adverse cardiovascular events through 24 months. RESULTS: The sponsor terminated the study for strategic considerations after enrollment of 112 of planned 444 patients. The difference in TET between patients treated with cell therapy versus placebo was 61.0 s at 3 months (95% confidence interval (CI): -2.9 to 124.8; p = 0.06), 46.2 s at 6 months (95% CI: -28.0 to 120.4; p = 0.22), and 36.6 s at 12 months (95% CI: -56.1 to 129.2; p = 0.43); angina frequency was improved at 6 months (relative risk: 0.63; p = 0.05). Autologous CD34(+) cell therapy seemed to be safe compared with both open-label standard of care and active control (major adverse cardiovascular events 67.9% [standard of care], 42.9% (active control), 46.0% [CD34(+)]). CONCLUSIONS: Due to early termination, RENEW was an incomplete experiment; however, the results were consistent with observations from earlier phase studies. These findings underscore the need for a definitive trial. (Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34(+) Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina [RENEW]: NCT01508910).

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Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

August 8, 2016

Volume

9

Issue

15

Start / End Page

1576 / 1585

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Transplantation, Autologous
  • Time Factors
  • Stem Cell Transplantation
  • Risk Factors
  • Recovery of Function
  • Neovascularization, Physiologic
  • Middle Aged
  • Male
 

Citation

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Povsic, T. J., Henry, T. D., Traverse, J. H., Fortuin, F. D., Schaer, G. L., Kereiakes, D. J., … RENEW Investigators, . (2016). The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina. JACC Cardiovasc Interv, 9(15), 1576–1585. https://doi.org/10.1016/j.jcin.2016.05.003
Povsic, Thomas J., Timothy D. Henry, Jay H. Traverse, F David Fortuin, Gary L. Schaer, Dean J. Kereiakes, Richard A. Schatz, et al. “The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina.JACC Cardiovasc Interv 9, no. 15 (August 8, 2016): 1576–85. https://doi.org/10.1016/j.jcin.2016.05.003.
Povsic TJ, Henry TD, Traverse JH, Fortuin FD, Schaer GL, Kereiakes DJ, et al. The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1576–85.
Povsic, Thomas J., et al. “The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina.JACC Cardiovasc Interv, vol. 9, no. 15, Aug. 2016, pp. 1576–85. Pubmed, doi:10.1016/j.jcin.2016.05.003.
Povsic TJ, Henry TD, Traverse JH, Fortuin FD, Schaer GL, Kereiakes DJ, Schatz RA, Zeiher AM, White CJ, Stewart DJ, Jolicoeur EM, Bass T, Henderson DA, Dignacco P, Gu Z, Al-Khalidi HR, Junge C, Nada A, Hunt AS, Losordo DW, RENEW Investigators. The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1576–1585.
Journal cover image

Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

August 8, 2016

Volume

9

Issue

15

Start / End Page

1576 / 1585

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Transplantation, Autologous
  • Time Factors
  • Stem Cell Transplantation
  • Risk Factors
  • Recovery of Function
  • Neovascularization, Physiologic
  • Middle Aged
  • Male