Heart FailurePhase 2NCT01758406
Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure
A Phase 2 study testing Intracoronary injection in people with Heart Failure, run by Royan Institute at 1 site in Iran.
Trial summary
This study is a prospective, randomized, double blind , controlled trial to assess the efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients with ischemic heart failure. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Intracoronary injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Dec 2013to Dec 2017
- Phase
- Phase 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1- EF≤40 (by Echocardiography) 2- Not responding to standard therapies for heart failure >1m 3- NYHA class ≥ III 4- Myocardial infarction due to coronary artery atherosclerotic disease 5-An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI) 6-No HIV/Viral hepatitis 7-Normal liver function (SGPT < 3 times the upper reference range) 8-No or controlled diabetes (hemoglobin A1C < 8.5%) 9- Ability to provide informed consent and follow-up with protocol procedures
Who cannot join
- 1 prior ICD placement(<2w)/Sustained ventricular arrhythmias 2-Cardiogenic shock 3- pregnancy and Child-bearing 4- Congenital / valvular heart disease
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehran
Nasser Aghdami, MD,PhD, +982123562000 ext. 504, nasser.aghdami@royaninstitute.org
Leila Arab, MD, +982123562000 ext. 414, leila.arab@yahoo.com
About this study
Official title: Therapeutic Outcome of Intracoronary Transplantation of Autologous Cardiac Stem Cells in Patients With Ischemic Heart Failure: Randomized Double Blind Clinical Trial
This study is a prospective, randomized, double blind , controlled trial to assess the efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients with ischemic heart failure.
Read the detailed description
Heart failure is a common, costly, disabling, and potentially deadly condition. Heart transplantation is the ultimate approach to treating heart failure, but this is costly and excludes patients who are poor candidates for transplantation given their co morbidities, or for whom a donor organ is unavailable. Currently, there is no effective intervention to regenerate dead heart muscle after a heart attack. Our hypothesis is that CSCs regenerates myocardium. In this study all eligible patients are randomly allocated into two study groups by a permuted block randomization method: group A (case group) received 5-10 millions autologous cardiac stem cells, group B (control group) just received placebo. They follow up for 18 months.
- Conditions
- Heart Failure
- Being tested
- Intracoronary injection, Intracoronary injection of Placebo
- Keywords
- Cardiac stem ce heart failure cardiac function intracoronary transplantation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary injectionBiological
Also called autologous cardiac stem cell intracoronary injection
stem cell transplantation
Intracoronary injection of PlaceboBiological
Injection of Placebo via coronary arteries in patients with heart failure.
| Study group | Role | What they receive |
|---|---|---|
| cardiac stem cell transplantation | Experimental | The patients with heart failure that underwent cardiac stem cell transplantation. Receives: Biological: Intracoronary injection |
| Placebo | Placebo comparator | The patients with heart failure that underwent placebo injection. Receives: Biological: Intracoronary injection of Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
evaluation the rate of patients mortality after cardiac stem cell transplantation.
Measured: 18months
arrhythmia
Evaluation rate of arrhythmia after cardiac stem cell transplantation
Measured: 18months
hospitalization
Evaluation the rate of hospitalization after cardiac stem cell transplantation
Measured: 18 months
Secondary outcomes (4)
Ejectin fraction changes
evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation.
Measured: 18months
Pro BNP changes
Evaluation the reduction of Pro BNP in patients after cardiac stem cell transplantation.
Measured: 18months
NYHA functional class
Evaluation the improvement of NYHA functional class in patients after cardiac stem cell transplantation.
Measured: 18months
6MW test
Evaluation the improvement of 6MW test after cardiac stem cell transplantation.
Measured: 18months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of Royan department of degenerative medicineAhmad Amin, MD, Study director, Department of Heart failure,Shahid Rajaee HospitalFarveh Vakilian, MD, Principal investigator, Department of Heart failure , Imam reza hospital, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758406
- Sponsor's protocol ID
- Royan-Heart-003
- Status last verified
- Nov 2015
- First submitted
- 24 Dec 2012
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Outcome of Intracoronary Transplantation of Autologous Cardiac Stem Cells in Patients With Ischemic Heart Failure: Randomized Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01758406
- Acronym / sponsor ID
- Royan-Heart-003
- Conditions
- Heart Failure
- Keywords
- Cardiac stem ce heart failure cardiac function intracoronary transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Dec 2013
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 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.
This study is a prospective, randomized, double blind , controlled trial to assess the efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients with ischemic heart failure.
Detailed description
Heart failure is a common, costly, disabling, and potentially deadly condition. Heart transplantation is the ultimate approach to treating heart failure, but this is costly and excludes patients who are poor candidates for transplantation given their co morbidities, or for whom a donor organ is unavailable. Currently, there is no effective intervention to regenerate dead heart muscle after a heart attack. Our hypothesis is that CSCs regenerates myocardium. In this study all eligible patients are randomly allocated into two study groups by a permuted block randomization method: group A (case group) received 5-10 millions autologous cardiac stem cells, group B (control group) just received placebo. They follow up for 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiac stem cell transplantation | Experimental | Biological: Intracoronary injectionThe patients with heart failure that underwent cardiac stem cell transplantation. |
| Placebo | Placebo comparator | Biological: Intracoronary injection of PlaceboThe patients with heart failure that underwent placebo injection. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1- EF≤40 (by Echocardiography) 2- Not responding to standard therapies for heart failure >1m 3- NYHA class ≥ III 4- Myocardial infarction due to coronary artery atherosclerotic disease 5-An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI) 6-No HIV/Viral hepatitis 7-Normal liver function (SGPT < 3 times the upper reference range) 8-No or controlled diabetes (hemoglobin A1C < 8.5%) 9- Ability to provide informed consent and follow-up with protocol procedures
Key exclusion criteria (1 listed)
- 1 prior ICD placement(<2w)/Sustained ventricular arrhythmias 2-Cardiogenic shock 3- pregnancy and Child-bearing 4- Congenital / valvular heart 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 |
|---|---|---|
| Intracoronary injectionAlso: autologous cardiac stem cell intracoronary injectionstem cell transplantation | Biological | cardiac stem cell transplantation |
| Intracoronary injection of PlaceboInjection of Placebo via coronary arteries in patients with heart failure. | Biological | Placebo |
Primary outcome
death
Time frame: 18months
evaluation the rate of patients mortality after cardiac stem cell transplantation.
arrhythmia
Time frame: 18months
Evaluation rate of arrhythmia after cardiac stem cell transplantation
hospitalization
Time frame: 18 months
Evaluation the rate of hospitalization after cardiac stem cell transplantation
4 secondary outcomes
Ejectin fraction changes
Time frame: 18months
Pro BNP changes
Time frame: 18months
NYHA functional class
Time frame: 18months
6MW test
Time frame: 18months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of Royan department of degenerative medicine
Ahmad Amin, MD study director
Department of Heart failure,Shahid Rajaee 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 study testing Intracoronary injection in people with Heart Failure, run by Royan Institute at 1 site in Iran.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 2015. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser Aghdami, MD,PhD (+9821235622000 ext. 504, nasser.aghdami@royaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 18months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.