Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis in Patients With Dilated Cardiomyopathy - POSEIDON-DCM

Nov 14, 2016
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Presenter/Author:
Joshua M. Hare, MD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Heart, Lung, and Blood Institute
Date Presented:
11/14/2016
Date Published:
11/14/2016
Date Updated:
11/14/2016
Original Posted Date:
11/14/2016
References

Contribution To Literature:

The POSEIDON-DCM pilot study demonstrated the safety of transendocardial stem cell injection in dilated cardiomyopathy.

Description:

The goal of the trial was to evaluate treatment with allogenic compared with autologous bone marrow-derived mesenchymal stem cells among patients with nonischemic dilated cardiomyopathy.

Study Design

  • Randomized
  • Parallel

Patients with nonischemic dilated cardiomyopathy were randomized to transendocardial injection in 10 left ventricular (LV) sites with the NOGA catheter of allogenic (n = 18) versus autologous stem cells (n = 16).

Inclusion criteria:

  • Patients with nonischemic dilated cardiomyopathy
  • LV ejection fraction (LVEF) <40%
  • LV end-diastolic diameter >5.9 cm (>5.6 cm in women) or LV end-diastolic volume index >125 cc/m2
  • Total number of enrollees: 37
  • Duration of follow-up: 12 months
  • Mean patient age: 56 years
  • Percentage female: 32%

Principal Findings:

The primary safety outcome, treatment-emergent serious adverse events within 30 days, occurred in none of the allogenic stem cell group versus none of the autologous stem cell group.

Secondary outcomes:

  • Serious adverse events at 12 months: 28% in the allogenic group versus 64% in the autologous group (p = 0.10)
  • Change in LVEF: 8.0% in the allogenic group versus 5.4% in the autologous group (p = 0.49)
  • Change in 6-minute walk test: 37 m in the allogenic group versus 7.3 m in the autologous group (p = 0.012)

Interpretation:

Among patients with a nonischemic dilated cardiomyopathy, transendocardial injection of bone marrow-derived stem cells (allogenic vs. autologous) was feasible. This small pilot study demonstrated the safety of endocardial stem cell injection. Large studies are warranted to evaluate the clinical efficacy of this treatment approach.

References:

Hare JM, DiFede DL, Castellanos AM, et al. Randomized Comparison of Allogenic vs. Autologous Mesenchymal Stem Cells for Non-Ischemic Dilated Cardiomyopathy: POSEIDON-DCM Trial. J Am Coll Cardiol 2016;Nov 14:[Epub ahead of print].

Presented by Dr. Joshua M. Hare at the American Heart Association Annual Scientific Sessions (AHA 2016), New Orleans, LA, November 14, 2016.

Keywords: AHA Annual Scientific Sessions, Bone Marrow, Cardiomyopathy, Dilated, Endocardium, Heart Failure, Mesenchymal Stem Cell Transplantation, Mesenchymal Stem Cells, Stem Cells, Stroke Volume, Transplantation, Autologous, Transplantation, Homologous, Treatment Outcome, Ventricular Function, Left


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