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ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) Trial: Rationale and Design.

Publication ,  Journal Article
Chakravarty, T; Makkar, RR; Ascheim, DD; Traverse, JH; Schatz, R; DeMaria, A; Francis, GS; Povsic, TJ; Smith, RR; Lima, JA; Pogoda, JM ...
Published in: Cell Transplant
February 16, 2017

Autologous cardiosphere-derived cells (CDCs) were the first therapeutic modality to demonstrate myocardial regeneration with a decrease in scar size and an increase in viable, functional tissue. Widespread applicability of autologous CDC therapy is limited by the need for patient-specific myocardial biopsy, cell processing, and quality control, resulting in delays to therapy and inherent logistical and economic constraints. Preclinical data had demonstrated equivalent efficiency of allogeneic to autologous CDCs. The ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial is a multicenter randomized, double-blind, placebo-controlled phase 1/2 safety and efficacy trial of intracoronary delivery of allogeneic CDCs (CAP-1002) in patients with myocardial infarction (MI) and ischemic left ventricular dysfunction. The phase 1 safety cohort enrolled 14 patients in an open-label, nonrandomized, dose-escalation safety trial. The phase 2 trial is a double-blind, randomized, placebo-controlled trial that will compare intracoronary CDCs to placebo in a 2:1 allocation and will enroll up to 120 patients. The primary endpoint for both phases is safety at 1 month. For phase 2, the primary efficacy endpoint is relative change from baseline in infarct size at 12 months, as assessed by magnetic resonance imaging. The ALLSTAR trial employs a "seamless" WOVE 1 design that enables continuous enrollment from phase 1 to phase 2 and will evaluate the safety of intracoronary administration of allogeneic CDCs and its efficacy in decreasing infarct size in post-MI patients.

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Published In

Cell Transplant

DOI

EISSN

1555-3892

Publication Date

February 16, 2017

Volume

26

Issue

2

Start / End Page

205 / 214

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • Transplantation, Autologous
  • Stem Cells
  • Stem Cell Transplantation
  • Regenerative Medicine
  • Neurology & Neurosurgery
  • Myocytes, Cardiac
  • Myocardial Infarction
  • Male
  • Humans
 

Citation

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Chicago
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Chakravarty, T., Makkar, R. R., Ascheim, D. D., Traverse, J. H., Schatz, R., DeMaria, A., … Henry, T. D. (2017). ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) Trial: Rationale and Design. Cell Transplant, 26(2), 205–214. https://doi.org/10.3727/096368916X692933
Chakravarty, Tarun, Raj R. Makkar, Deborah D. Ascheim, Jay H. Traverse, Richard Schatz, Anthony DeMaria, Gary S. Francis, et al. “ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) Trial: Rationale and Design.Cell Transplant 26, no. 2 (February 16, 2017): 205–14. https://doi.org/10.3727/096368916X692933.
Chakravarty T, Makkar RR, Ascheim DD, Traverse JH, Schatz R, DeMaria A, et al. ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) Trial: Rationale and Design. Cell Transplant. 2017 Feb 16;26(2):205–14.
Chakravarty, Tarun, et al. “ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) Trial: Rationale and Design.Cell Transplant, vol. 26, no. 2, Feb. 2017, pp. 205–14. Pubmed, doi:10.3727/096368916X692933.
Chakravarty T, Makkar RR, Ascheim DD, Traverse JH, Schatz R, DeMaria A, Francis GS, Povsic TJ, Smith RR, Lima JA, Pogoda JM, Marbán L, Henry TD. ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) Trial: Rationale and Design. Cell Transplant. 2017 Feb 16;26(2):205–214.
Journal cover image

Published In

Cell Transplant

DOI

EISSN

1555-3892

Publication Date

February 16, 2017

Volume

26

Issue

2

Start / End Page

205 / 214

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • Transplantation, Autologous
  • Stem Cells
  • Stem Cell Transplantation
  • Regenerative Medicine
  • Neurology & Neurosurgery
  • Myocytes, Cardiac
  • Myocardial Infarction
  • Male
  • Humans