Heart FailurePhase 1/2ICMNC-HFNCT03145402
ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
A Phase 1/2 study testing Intracoronary injection of stem cell in people with Heart Failure, run by SCARM Institute, Tabriz, Iran at 1 site in Iran.
Trial summary
This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess that a single intracoronary infusion of autologous bone marrow-mononuclear cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Intracoronary injection of stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteIran
- Study dates
- 20 Oct 2020to 2 Oct 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women of any ethnic origin 18 ≤ aged≤ 65 years
- EF≤40 (by Echocardiography) and regional wall motion abnormality
- Not responding to standard therapies
- the New York Heart Association (NYHA) class ≥ III
- Myocardial infarction due to coronary artery atherosclerotic disease
- An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)
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- Normal liver and renal function
- No or controlled diabetes
- Able to give voluntary written consent and understand the study information provided to him
Who cannot join
- Participation in another clinical trial within 30 days prior randomisation
- Previously received stem/progenitor cell therapy
- Pregnant women
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
- Cardiogenic shock requiring mechanical support
- Congenital / valvular heart disease
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- Implantable cardioverter defibrillator (ICD) transplant
- Platelet count <100.000/µl, or hemoglobin <8.5 g/dl
- Impaired renal function, i.e. creatinine >2.5 mg/dl
- Fever or diarrhea within 4 weeks prior screening
- History of bleeding disorder within 3 months prior screening
- Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) or Sustained ventricular arrhythmia
- Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease
Trial locations and contacts
1 site in 1 country.
Iran1 site
Stem Cell And Regenerative Medicine institute (SCARM)
Tabriz
Peyman Keyhanvar, MD, Ph.D, 0914 114 6863
Yousef Faridvand, Ph.D
About this study
Official title: The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation in Heart Failure (HF) Patients
This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess that a single intracoronary infusion of autologous bone marrow-mononuclear cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.
- Conditions
- Heart Failure
- Being tested
- Intracoronary injection of stem cell, Placebo
- 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 injection of stem cellBiological
Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques.
PlaceboBiological
Injection of Placebo in patients with Heart failure via coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary injection of stem cell | Experimental | Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure Receives: Biological: Intracoronary injection of stem cell |
| Placebo | Placebo comparator | Placebo injection via coronary arteries in patients with Heart Failure Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
The rate of patients mortality after transplantation
Measured: 12 months
Hospitalization
the rate of hospitalization after transplantation
Measured: 12 months
Secondary outcomes (4)
Ejection fraction changes
Elevation of ejection fraction in patients after transplantation
Measured: 12 months
6-minute walk test (6MWT)
Evaluation the improvement of 6MWT test after transplantation
Measured: 12 months
Pro b-type natriuretic peptide (Pro-BNP) changes
Elevation the reduction of Pro-BNP in patients after transplantation
Measured: 12 months
NYHA functional class
Evaluation the improvement of NYHA functional class in patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start20 Oct 2020 (estimated)
- Primary completion28 Aug 2021 (estimated)
- Study completion2 Oct 2021 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCARM Institute, Tabriz, Iran
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nasser Aslanabadi, MD, Cardiologist, Study director, Tabriz University of Medical SciencesMohammad Nouri, Ph.D, Study chair, Head of SCARM institutePeyman Keyhanvar, MD, Ph.D, Principal investigator, Deputy for translational medicine of SCARM instituteRaheleh Farahzadi, Ph.D, Principal investigator, Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, IranYousef Faridvand, Ph.D, Principal investigator, SCARM instituteElgar Anamzadeh, MD, Cardiologist, Principal investigator, Tabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145402
- Sponsor's protocol ID
- SCARM-Heart-001
- Acronym
- ICMNC-HF
- Status last verified
- Dec 2019
- First submitted
- 2 May 2017
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation in Heart Failure (HF) Patients
- ClinicalTrials.gov ID
- NCT03145402
- Acronym / sponsor ID
- ICMNC-HF / SCARM-Heart-001
- Conditions
- Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- SCARM Institute, Tabriz, IranOther government
- Study start
- 20 Oct 2020 (estimated)
- Primary completion
- 28 Aug 2021 (estimated)
- Study completion
- 2 Oct 2021 (estimated)
- First posted
- 9 May 2017 (actual)
- 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 is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess that a single intracoronary infusion of autologous bone marrow-mononuclear cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracoronary injection of stem cell | Experimental | Biological: Intracoronary injection of stem cellAutologous bone marrow-derived mononuclear cells injection in patients with Heart Failure |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo injection via coronary arteries in patients with Heart Failure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women of any ethnic origin 18 ≤ aged≤ 65 years
- EF≤40 (by Echocardiography) and regional wall motion abnormality
- Not responding to standard therapies
- the New York Heart Association (NYHA) class ≥ III
- Myocardial infarction due to coronary artery atherosclerotic disease
Key exclusion criteria (13 listed)
- Participation in another clinical trial within 30 days prior randomisation
- Previously received stem/progenitor cell therapy
- Pregnant women
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
- Cardiogenic shock requiring mechanical support
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 injection of stem cellAutologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques. | Biological | Intracoronary injection of stem cell |
| PlaceboInjection of Placebo in patients with Heart failure via coronary arteries | Biological | Placebo |
Primary outcome
Death
Time frame: 12 months
The rate of patients mortality after transplantation
Hospitalization
Time frame: 12 months
the rate of hospitalization after transplantation
4 secondary outcomes
Ejection fraction changes
Time frame: 12 months
6-minute walk test (6MWT)
Time frame: 12 months
Pro b-type natriuretic peptide (Pro-BNP) changes
Time frame: 12 months
NYHA functional class
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Nasser Aslanabadi, MD, Cardiologist study director
Tabriz University of Medical Sciences
Mohammad Nouri, Ph.D study chair
Head of SCARM institute
Peyman Keyhanvar, MD, Ph.D principal investigator
Deputy for translational medicine of SCARM institute
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 Intracoronary injection of stem cell in people with Heart Failure, run by SCARM Institute, Tabriz, Iran 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 9 inclusion and 13 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 17 Mar 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser Aslanabadi, MD, Cardiologist (0413 33349525, aslanabadin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (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?
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 17 Mar 2020.