Heart FailurePhase 2/3NCT01759212
Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure.
A Phase 2/3 study testing Allogeneic stem cells implantation in people with Heart Failure and Ischemic Cardiomyopathy, run by AHEPA University Hospital at 1 site in Greece.
Trial summary
The aim of the study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy undergoing left ventricular assist device implantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Ischemic Cardiomyopathy
- What is being tested?
- Allogeneic stem cells implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2012to Jul 2022
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years
- End-stage heart failure due to ischemic cardiomyopathy that requires mechanical support according to current indications
- Ability to provide informed consent
Who cannot join
- Not willing to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation
The aim of the study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy undergoing left ventricular assist device implantation.
Read the detailed description
End-stage ischemic cardiomyopathy (ICM) with non-graftable coronary arteries is a common and debilitating problem. The ultimate therapeutic goal in such cases is cardiac transplantation which is restricted by donor availability. Alternatively, left ventricular assist devices (LVAD) are increasingly used as bridge to transplantation or more recently as destination therapy in non-transplant candidates. Widely used second- and third-generation continuous-flow LVAD offer symptomatic relief and prolong life. However, LV unloading rarely improves native heart function in ischemic hearts. We aim to increase myocardial viability and improve native cardiac function in patients with end-stage ICM by injecting allogeneic bone marrow stem cells at the time of LVAD implantation.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy
- Being tested
- Allogeneic stem cells implantation
- Keywords
- stem cell implantation, coronary artery disease, left ventricular assist device
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic stem cells implantationBiological
| Study group | Role | What they receive |
|---|---|---|
| Stem cells implantation | Experimental | Patients with end-stage heart failure due to ischemic cardiomyopathy will undergo combined cellular and mechanical support with implantation of off-the-shelf allogeneic mesenchymal stem cells and left ventricular assist device. Receives: Biological: Allogeneic stem cells implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in myocardial perfusion/viability
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
Measured: 12 months
Improvement in myocardial perfusion/viability
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
Measured: 24 months
Secondary outcomes (2)
Morbidity
Major adverse cardiac and cerebrovascular events
Measured: 12 months
Change in left ventricular function
Change in left ventricular function after combined mechanical and cellular therapy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2022
- Study completionJul 2022
Why it stopped: Lack of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyriakos Anastasiadis, AHEPA University Hospital
- Investigators
- Kyriakos Anastasiadis, MD, PhD, FETCS, Principal investigator, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759212
- Sponsor's protocol ID
- AHEPA_CTL_02
- Status last verified
- Jul 2022
- First submitted
- 18 Dec 2012
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Anastasiadis K, Antonitsis P, Doumas A, Koliakos G, Argiriadou H, Vaitsopoulou C, Tossios P, Papakonstantinou C, Westaby S. Stem cells transplantation combined with long-term mechanical circulatory support enhances myocardial viability in end-stage ischemic cardiomyopathy. Int J Cardiol. 2012 Mar 22;155(3):e51-3. doi: 10.1016/j.ijcard.2011.07.062. Epub 2011 Aug 17. No abstract available.
PubMed 21852003Anastasiadis K, Antonitsis P, Argiriadou H, Koliakos G, Doumas A, Khayat A, Papakonstantinou C, Westaby S. Hybrid approach of ventricular assist device and autologous bone marrow stem cells implantation in end-stage ischemic heart failure enhances myocardial reperfusion. J Transl Med. 2011 Jan 19;9:12. doi: 10.1186/1479-5876-9-12.
PubMed 21247486Ibrahim M, Rao C, Athanasiou T, Yacoub MH, Terracciano CM. Mechanical unloading and cell therapy have a synergistic role in the recovery and regeneration of the failing heart. Eur J Cardiothorac Surg. 2012 Aug;42(2):312-8. doi: 10.1093/ejcts/ezs067. Epub 2012 Feb 29.
PubMed 22378852
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT01759212
- Acronym / sponsor ID
- AHEPA_CTL_02
- Conditions
- Heart Failure, Ischemic Cardiomyopathy
- Keywords
- stem cell implantation, coronary artery disease, left ventricular assist device
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 3 Jan 2013 (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 aim of the study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy undergoing left ventricular assist device implantation.
Detailed description
End-stage ischemic cardiomyopathy (ICM) with non-graftable coronary arteries is a common and debilitating problem. The ultimate therapeutic goal in such cases is cardiac transplantation which is restricted by donor availability. Alternatively, left ventricular assist devices (LVAD) are increasingly used as bridge to transplantation or more recently as destination therapy in non-transplant candidates. Widely used second- and third-generation continuous-flow LVAD offer symptomatic relief and prolong life. However, LV unloading rarely improves native heart function in ischemic hearts. We aim to increase myocardial viability and improve native cardiac function in patients with end-stage ICM by injecting allogeneic bone marrow stem cells at the time of LVAD implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cells implantation | Experimental | Biological: Allogeneic stem cells implantationPatients with end-stage heart failure due to ischemic cardiomyopathy will undergo combined cellular and mechanical support with implantation of off-the-shelf allogeneic mesenchymal stem cells and left ventricular assist device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 75 years
- End-stage heart failure due to ischemic cardiomyopathy that requires mechanical support according to current indications
- Ability to provide informed consent
Key exclusion criteria (1 listed)
- Not willing to provide informed consent
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 |
|---|---|---|
| Allogeneic stem cells implantation | Biological | Stem cells implantation |
Primary outcome
Improvement in myocardial perfusion/viability
Time frame: 12 months
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
Improvement in myocardial perfusion/viability
Time frame: 24 months
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
2 secondary outcomes
Morbidity
Time frame: 12 months
Change in left ventricular function
Time frame: one year
Results and safety
The study was stopped early (reason given: Lack of eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Background: PubMed 21852003Anastasiadis K, Antonitsis P, Doumas A, Koliakos G, Argiriadou H, Vaitsopoulou C, Tossios P, Papakonstantinou C, Westaby S. Stem cells transplantation combined with long-term mechanical circulatory support enhances myocardial viability in end-stage ischemic cardiomyopathy. Int J Cardiol. 2012 Mar 22;155(3):e51-3. doi: 10.1016/j.ijcard.2011.07.062. Epub 2011 Aug 17. No abstract available.
- Background: PubMed 21247486Anastasiadis K, Antonitsis P, Argiriadou H, Koliakos G, Doumas A, Khayat A, Papakonstantinou C, Westaby S. Hybrid approach of ventricular assist device and autologous bone marrow stem cells implantation in end-stage ischemic heart failure enhances myocardial reperfusion. J Transl Med. 2011 Jan 19;9:12. doi: 10.1186/1479-5876-9-12.
- Background: PubMed 22378852Ibrahim M, Rao C, Athanasiou T, Yacoub MH, Terracciano CM. Mechanical unloading and cell therapy have a synergistic role in the recovery and regeneration of the failing heart. Eur J Cardiothorac Surg. 2012 Aug;42(2):312-8. doi: 10.1093/ejcts/ezs067. Epub 2012 Feb 29.
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
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.
Kyriakos Anastasiadis, MD, PhD, FETCS principal investigator
AHEPA University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Allogeneic stem cells implantation in people with Heart Failure and Ischemic Cardiomyopathy, run by AHEPA University Hospital at 1 site in Greece.
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 3 inclusion and 1 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 25 Jul 2022. 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 Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Lack of eligible patients). 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?
Improvement in myocardial perfusion/viability (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01759212, which also lists 3 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 25 Jul 2022.