title: Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting.
abstract: Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30-80) with left ventricle ejection fractions ranging between 25 and 45% will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months.
authors.affiliation: Department of Histology and Embryology, Laboratory for Stem Cells and Reproductive Cell Biology, Ankara University School of Medicine, Ankara, Turkey, alpcan@medicine.ankara.edu.tr.
authors.forename: Alp
authors.initials: A
authors.lastname: Can
authors.forename: Ahmet Tulga
authors.initials: AT
authors.lastname: Ulus
authors.forename: Ozgur
authors.initials: O
authors.lastname: Cinar
authors.forename: Ferda
authors.initials: F
authors.lastname: Topal Celikkan
authors.forename: Erdal
authors.initials: E
authors.lastname: Simsek
authors.forename: Mesut
authors.initials: M
authors.lastname: Akyol
authors.forename: Ugur
authors.initials: U
authors.lastname: Canpolat
authors.forename: Murat
authors.initials: M
authors.lastname: Erturk
authors.forename: Fadil
authors.initials: F
authors.lastname: Kara
authors.forename: Osman
authors.initials: O
authors.lastname: Ilhan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001026:Coronary Artery Bypass / Q000379:methods; D003324:Coronary Artery Disease / Q000601:surgery; D006321:Heart / Q000503:physiopathology; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000601:surgery*; D016896:Treatment Outcome; D014470:Umbilical Cord / Q000166:cytology*; D016277:Ventricular Function, Left / Q000502:physiology