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Autologous CD34+ Cell Therapy for Refractory Angina: 2-Year Outcomes From the ACT34-CMI Study.

Publication ,  Journal Article
Henry, TD; Schaer, GL; Traverse, JH; Povsic, TJ; Davidson, C; Lee, JS; Costa, MA; Bass, T; Mendelsohn, F; Fortuin, FD; Pepine, CJ; Patel, AN ...
Published in: Cell Transplant
2016

An increasing number of patients have refractory angina despite optimal medical therapy and are without further revascularization options. Preclinical studies indicate that human CD34+ stem cells can stimulate new blood vessel formation in ischemic myocardium, improving perfusion and function. In ACT34-CMI (N = 167), patients treated with autologous CD34+ stem cells had improvements in angina and exercise time at 6 and 12 months compared to placebo; however, the longer-term effects of this treatment are unknown. ACT34 was a phase II randomized, double-blind, placebo-controlled clinical trial comparing placebo, low dose (1 × 105 CD34/kg body weight), and high dose (5 × 105 CD34/kg) using intramyocardial delivery into the ischemic zone following NOGA® mapping. To obtain longer-term safety and efficacy in these patients, we compiled data of major adverse cardiac events (MACE; death, myocardial infarction, acute coronary syndrome, or heart failure hospitalization) up to 24 months as well as angina and quality of life assessments in patients who consented for 24-month follow-up. A total of 167 patients with class III-IV refractory angina were randomized and completed the injection procedure. The low-dose-treated patients had a significant reduction in angina frequency (p = 0.02, 0.035) and improvements in exercise tolerance testing (ETT) time (p = 0.014, 0.017) compared to the placebo group at 6 and 12 months. At 24 months, patients treated with both low-and high-dose CD34+ cells had significant reduction in angina frequency (p = 0.03). At 24 months, there were a total of seven deaths (12.5%) in the control group versus one (1.8%) in the low-dose and two (3.6%) in the high-dose (p = 0.08) groups. At 2 years, MACE occurred at a rate of 33.9%, 21.8%, and 16.2% in control, low-, and high-dose patients, respectively (p = 0.08). Autologous CD34+ cell therapy was associated with persistent improvement in angina at 2 years and a trend for reduction in mortality in no-option patients with refractory angina.

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Published In

Cell Transplant

DOI

EISSN

1555-3892

Publication Date

2016

Volume

25

Issue

9

Start / End Page

1701 / 1711

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Autologous
  • Stem Cells
  • Neurology & Neurosurgery
  • Myocardium
  • Humans
  • Exercise Test
  • Double-Blind Method
  • Cell- and Tissue-Based Therapy
  • Antigens, CD34
 

Citation

APA
Chicago
ICMJE
MLA
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Henry, T. D., Schaer, G. L., Traverse, J. H., Povsic, T. J., Davidson, C., Lee, J. S., … ACT, . (2016). Autologous CD34+ Cell Therapy for Refractory Angina: 2-Year Outcomes From the ACT34-CMI Study. Cell Transplant, 25(9), 1701–1711. https://doi.org/10.3727/096368916X691484
Henry, Timothy D., Gary L. Schaer, Jay H. Traverse, Thomas J. Povsic, Charles Davidson, Joon Sup Lee, Marco A. Costa, et al. “Autologous CD34+ Cell Therapy for Refractory Angina: 2-Year Outcomes From the ACT34-CMI Study.Cell Transplant 25, no. 9 (2016): 1701–11. https://doi.org/10.3727/096368916X691484.
Henry TD, Schaer GL, Traverse JH, Povsic TJ, Davidson C, Lee JS, et al. Autologous CD34+ Cell Therapy for Refractory Angina: 2-Year Outcomes From the ACT34-CMI Study. Cell Transplant. 2016;25(9):1701–11.
Henry, Timothy D., et al. “Autologous CD34+ Cell Therapy for Refractory Angina: 2-Year Outcomes From the ACT34-CMI Study.Cell Transplant, vol. 25, no. 9, 2016, pp. 1701–11. Pubmed, doi:10.3727/096368916X691484.
Henry TD, Schaer GL, Traverse JH, Povsic TJ, Davidson C, Lee JS, Costa MA, Bass T, Mendelsohn F, Fortuin FD, Pepine CJ, Patel AN, Riedel N, Junge C, Hunt A, Kereiakes DJ, White C, Harrington RA, Schatz RA, Losordo DW, ACT. Autologous CD34+ Cell Therapy for Refractory Angina: 2-Year Outcomes From the ACT34-CMI Study. Cell Transplant. 2016;25(9):1701–1711.
Journal cover image

Published In

Cell Transplant

DOI

EISSN

1555-3892

Publication Date

2016

Volume

25

Issue

9

Start / End Page

1701 / 1711

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Autologous
  • Stem Cells
  • Neurology & Neurosurgery
  • Myocardium
  • Humans
  • Exercise Test
  • Double-Blind Method
  • Cell- and Tissue-Based Therapy
  • Antigens, CD34