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. (19th September 2017)

• Record Type: Journal Article
• Authors: Kastrup, Jens; Schou, Morten; Gustafsson, Ida; Nielsen, Olav W.; Møgelvang, Rasmus; Kofoed, Klaus F.; Kragelund, Charlotte; Hove, Jens Dahlgaard; Fabricius-Bjerre, Andreas; Heitman, Merete; Haack-Sørensen, Mandana; Lund, Lisbeth Drozd; Johansen, Ellen Mønsted; Qayyum, Abbas Ali; Mathiasen, Anders Bruun; Ekblond, Annette
• Other Names: Vrtovec Bojan Academic Editor.
• Is Part Of: Stem cells international. Volume 2017(2017)
• Publication Date: 2017-09-19
• Subjects: Stem Cells -- Periodicals; Stem Cells -- Therapeutic use -- Periodicals; Stem Cells -- Transplantation -- Periodicals; 616.0277405
• DOI: 10.1155/2017/8506370
• Languages: English
• ISSNs: 1687-966X

Abstract

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.