Clinical trial NCT02323477: Human Umbilical Cord Stroma MSC in Myocardial Infarction
Official title: The Efficacy and Safety Assessment of Human Umbilical Cord Stroma-derived Multipotent Stromal Cells in Myocardial Infarction; a Phase 1/2 Clinical Trial (HUC-HEART Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Ischemic Cardiomyopathy
Coronary Artery Bypass Surgery
Keywords: cellular therapy
chronic ischemic heart disease
phase 1/2 clinical study
human umbilical cord multipotent stem cell
human umbilical cord mesenchymal stem cell
ischemic heart disease
bone marrow mononuclear cell
allogeneic stem cell transplantation
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Turkiye Yuksek Ihtisas Education and Research Hospital
name: Atigen-Cell and Tissue Center
name: Dr. Sami Ulus Children's Hospital
name: Ankara Yildirim Beyazıt University
First posted: 2014-12-23
Enrollment: 46
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of allogeneic human umbilical cordstroma derived multipotent stem cells (hUCS-MSCs) in myocardial infarction (MI). All subjects will be taken into the bypass coronary surgery prior to the cell administration. This 2-year study comprise three independent groups, where the first group (n=20) will take no cells, second group will take autologous BM-MNCs (n=20), and third group (n=39) will be receiving allogeneic hUCS-MSCs. In all transplantations cells will be administered to the approximately 10 peri-infarct areas at one time. The infarct zone will be determined by the MR, SPECT and PET imaging. Only male subjects between 30-80 years of age. The efficiency of the therapy will be evaluated according to the parameters measured by MR, SPECT, and Echocardiography. All subject were taken into those measurements prior and 6, 12, 18 and 24 months after the operation.


Eligibility criteria: Inclusion Criteria:

* Ischemic hearth disease who will experience CABG
* %25\<EF\<%45
* NYHA class II-IV patients
* hemodynamically stable

Exclusion Criteria:

* Patient's in approval
* Acute cardiac decompensation
* Acute myocardial infarction
* Congenital heart disease
* Additional surgical heart disease other than coronary artery disease
* Malign arrhythmia
* All malignancies
* HbA1c level \>%10 (86 mmol/mol) type II diabetes mellitus
* Severe liver dysfunction
* Severe COPD
* Coagulopathy
* Immunosuppressive treatment
* Acute hepatitis, hepatitis B, C and HIV infection
* Chronic liver and renal failure
* Collagen tissue disease
* Stroke
* TB
* Hematological diseases
* Socially and mentally disabilities

Primary outcomes:
measure: ventricular remodeling
timeFrame: within one year after cell transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Alp Can
Study officials:
References:
citation: Ulus AT, Mungan C, Kurtoglu M, Celikkan FT, Akyol M, Sucu M, Toru M, Gul SS, Cinar O, Can A. Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells in Chronic Ischemic Cardiomyopathy: A Controlled, Randomized Clinical Trial (HUC-HEART Trial). Int J Stem Cells. 2020 Nov 30;13(3):364-376. doi: 10.15283/ijsc20075.
citation: Can A, Ulus AT, Cinar O, Topal Celikkan F, Simsek E, Akyol M, Canpolat U, Erturk M, Kara F, Ilhan O. 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. Stem Cell Rev Rep. 2015 Oct;11(5):752-60. doi: 10.1007/s12015-015-9601-0.