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Stem Cells International
Volume 2017, Article ID 8506370, 8 pages
https://doi.org/10.1155/2017/8506370
Clinical Study

Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study

1Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
2Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
3Department of Cardiology, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark
4Department of Radiology, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark
5Department of Cardiology, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark
6Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark
7Department of Radiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
8Department of Radiology, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark
9Department of Radiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark

Correspondence should be addressed to Jens Kastrup; kd.hnoiger@purtsak.snej

Received 31 May 2017; Accepted 24 August 2017; Published 19 September 2017

Academic Editor: Bojan Vrtovec

Copyright © 2017 Jens Kastrup et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. Ischemic heart failure (IHF) has a poor prognosis in spite of optimal therapy. We have established a new allogeneic Cardiology Stem Cell Centre adipose-derived stromal cell (CSCC_ASC) product from healthy donors. It is produced without animal products, in closed bioreactor systems and cryopreserved as an off-the-shelf product ready to use. Study Design. A multicentre, double-blind, placebo-controlled phase II study with direct intramyocardial injections of allogeneic CSCC_ASC in patients with chronic IHF. A total of 81 patients will be randomised at 2 : 1 to CSCC_ASC or placebo. There is no HLA tissue type matching needed between the patients and the donors. Methods. The treatment will be delivered by direct injections into the myocardium. The primary endpoint is change in the left ventricle endsystolic volume at 6-month follow-up. Secondary endpoints are safety and changes in left ventricle ejection fraction, myocardial mass, stroke volume, and cardiac output. Other secondary endpoints are change in clinical symptoms, 6-minute walking test, and the quality of life after 6 and 12 months. Conclusion. The aim of the present study is to demonstrate safety and the regenerative efficacy of the allogeneic CSCC_ASC product from healthy donors in a double-blind, placebo-controlled, multicentre study in patients with IHF.