Study Stopped
Due to budget limitations as allocated for a given period.
Human Umbilical Cord Stroma MSC in Myocardial Infarction
HUC-HEART
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)
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2015
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedStudy Start
First participant enrolled
February 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedJuly 10, 2020
July 1, 2020
3.7 years
December 18, 2014
July 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ventricular remodeling
Outcome measures will be determined by cardiac MR, SPECT and PET monitoring to assess the left ventricular ejection fraction (%), left ventricle end-diastolic and end-systolic volumes (mL/m2), left ventricle mass (g/m2), infarct size (%), and the thickness of the dysfunctional wall (mm).
within one year after cell transplantation
Study Arms (3)
Allogeneic umbilical cord MSC group
EXPERIMENTALAllogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF\<%45)
Autologous bone marrow-derived MNC group
ACTIVE COMPARATORAutologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF\<%45)
Control group
NO INTERVENTION20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF\<%45) whom will not received any further transplantation
Interventions
Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation
Eligibility Criteria
You may qualify if:
- Ischemic hearth disease who will experience CABG
- %25\<EF\<%45
- NYHA class II-IV patients
- hemodynamically stable
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ankara Universitylead
- Hacettepe Universitycollaborator
- Turkiye Yuksek Ihtisas Education and Research Hospitalcollaborator
- Atigen-Cell and Tissue Centercollaborator
- Dr. Sami Ulus Children's Hospitalcollaborator
- Ankara Yildirim Beyazıt Universitycollaborator
Study Sites (1)
Alp Can
Ankara, 06100, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 32840230DERIVEDCan 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.
PMID: 26123356DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
December 18, 2014
First Posted
December 23, 2014
Study Start
February 2, 2015
Primary Completion
September 30, 2018
Study Completion
December 30, 2018
Last Updated
July 10, 2020
Record last verified: 2020-07