ALLogeneic heart STem cells to achieve myocardial regeneration (ALLSTAR) trial: Rationale and design

Tarun Chakravarty, Raj R. Makkar, Deborah D. Ascheim, Jay H. Traverse, Richard Schatz, Anthony Demaria, Gary S. Francis, Thomas J. Povsic, Rachel R. Smith, Joao A. Lima, Janice M. Pogoda, Linda Marbán, Timothy D. Henry

Research output: Contribution to journalArticle

Abstract

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 doubleblind, 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.

LanguageEnglish (US)
Pages205-214
Number of pages10
JournalCell Transplantation
Volume26
Issue number2
DOIs
StatePublished - 2017

Fingerprint

Stem cells
Regeneration
Stem Cells
Safety
Placebos
Myocardial Infarction
Biopsy
Magnetic resonance
Left Ventricular Dysfunction
Quality control
Labels
Cell- and Tissue-Based Therapy
Quality Control
Cicatrix
Tissue
Imaging techniques
Randomized Controlled Trials
Economics
Magnetic Resonance Imaging
Processing

Keywords

  • Myocardial infarction (MI)
  • Regenerative medicine
  • ST elevation MI
  • Stem cells
  • Trial design

ASJC Scopus subject areas

  • Biomedical Engineering
  • Cell Biology
  • Transplantation

Cite this

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 Transplantation, 26(2), 205-214. DOI: 10.3727/096368916X692933

ALLogeneic heart STem cells to achieve myocardial regeneration (ALLSTAR) trial : Rationale and design. / Chakravarty, Tarun; Makkar, Raj R.; Ascheim, Deborah D.; Traverse, Jay H.; Schatz, Richard; Demaria, Anthony; Francis, Gary S.; Povsic, Thomas J.; Smith, Rachel R.; Lima, Joao A.; Pogoda, Janice M.; Marbán, Linda; Henry, Timothy D.

In: Cell Transplantation, Vol. 26, No. 2, 2017, p. 205-214.

Research output: Contribution to journalArticle

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 2017, 'ALLogeneic heart STem cells to achieve myocardial regeneration (ALLSTAR) trial: Rationale and design' Cell Transplantation, vol 26, no. 2, pp. 205-214. DOI: 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 Transplantation. 2017;26(2):205-214. Available from, DOI: 10.3727/096368916X692933
Chakravarty, Tarun ; Makkar, Raj R. ; Ascheim, Deborah D. ; Traverse, Jay H. ; Schatz, Richard ; Demaria, Anthony ; Francis, Gary S. ; Povsic, Thomas J. ; Smith, Rachel R. ; Lima, Joao A. ; Pogoda, Janice M. ; Marbán, Linda ; Henry, Timothy D./ ALLogeneic heart STem cells to achieve myocardial regeneration (ALLSTAR) trial : Rationale and design. In: Cell Transplantation. 2017 ; Vol. 26, No. 2. pp. 205-214
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