Chronic Ischemic CardiomyopathyPhase 1/2HUC-HEARTNCT02323477
Human Umbilical Cord Stroma MSC in Myocardial Infarction
A Phase 1/2 study testing stem cell transplantation in people with Chronic Ischemic Cardiomyopathy and Coronary Artery Bypass Surgery, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Chronic Ischemic Cardiomyopathy, Coronary Artery Bypass Surgery
- What is being tested?
- stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2015to 30 Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic hearth disease who will experience CABG
- %25<EF<%45
- NYHA class II-IV patients
- hemodynamically stable
Who cannot join
- Patient's in approval
- Acute cardiac decompensation
- Acute myocardial infarction
- Congenital heart disease
- Additional surgical heart disease other than coronary artery disease
- Malign arrhythmia
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- stem cell transplantation
- 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
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cell transplantationBiological
Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic umbilical cord MSC group | Experimental | Allogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45) Receives: Biological: stem cell transplantation |
| Autologous bone marrow-derived MNC group | Active comparator | Autologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45) Receives: Biological: stem cell transplantation |
| Control group | No intervention | 20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF<%45) whom will not received any further transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within one year after cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start2 Feb 2015
- Primary completion30 Sep 2018
- Study completion30 Dec 2018
Why it stopped: Due to budget limitations as allocated for a given period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Turkiye Yuksek Ihtisas Education and Research Hospital, Atigen-Cell and Tissue Center, Dr. Sami Ulus Children's Hospital, Ankara Yildirim Beyazıt University
- Responsible party
- Principal investigator, Alp Can, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323477
- Sponsor's protocol ID
- 741.STZ.2014
- Acronym
- HUC-HEART
- Status last verified
- Jul 2020
- First submitted
- 18 Dec 2014
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32840230Can 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.
PubMed 26123356
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02323477
- Acronym / sponsor ID
- HUC-HEART / 741.STZ.2014
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to budget limitations as allocated for a given period.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University, Turkiye Yuksek Ihtisas Education and Research Hospital, Atigen-Cell and Tissue Center, Dr. Sami Ulus Children's Hospital, Ankara Yildirim Beyazıt University
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allogeneic umbilical cord MSC group | Experimental | Biological: stem cell transplantationAllogeneic 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 comparator | Biological: stem cell transplantationAutologous 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 intervention | –20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF<%45) whom will not received any further transplantation |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic hearth disease who will experience CABG
- %25<EF<%45
- NYHA class II-IV patients
- hemodynamically stable
Key exclusion criteria (19 listed)
- Patient's in approval
- Acute cardiac decompensation
- Acute myocardial infarction
- Congenital heart disease
- Additional surgical heart disease other than coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stem cell transplantationHuman allogeneic umbilical cord MSC or autologous BM-MNC transplantation | Biological | Allogeneic umbilical cord MSC group, Autologous bone marrow-derived MNC group |
Primary outcome
ventricular remodeling
Time frame: within one year after cell transplantation
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).
Results and safety
The study was stopped early (reason given: Due to budget limitations as allocated for a given period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Derived from this study: PubMed 32840230Ulus 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.
- Derived from this study: PubMed 26123356Can 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing stem cell transplantation in people with Chronic Ischemic Cardiomyopathy and Coronary Artery Bypass Surgery, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to budget limitations as allocated for a given period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventricular remodeling (time frame: within one year after cell transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323477, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.