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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.

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.

SUBMITTER: Kastrup J

PROVIDER: S-EPMC5625749 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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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.

Kastrup Jens J Schou Morten M Gustafsson Ida I Nielsen Olav W OW Møgelvang Rasmus R Kofoed Klaus F KF Kragelund Charlotte C Hove Jens Dahlgaard JD Fabricius-Bjerre Andreas A Heitman Merete M Haack-Sørensen Mandana M Lund Lisbeth Drozd LD Johansen Ellen Mønsted EM Qayyum Abbas Ali AA Mathiasen Anders Bruun AB Ekblond Annette A

Stem cells international 20170919

<h4>Background</h4>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.<h4>Study design</h4>A multicentre, double-blind, placebo-controlled phase II study with direct intramyocardial injections of allogeneic CSC ...[more]

PMID: 29056973

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Dataset Information

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.

Publications

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.

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