Acute Myocardial InfarctionNCT00939042
Alster Stem Cells - Intramyocardial Stem Therapy
A study testing Percutaneous Coronary Intervention and BMNC therapy in people with Acute Myocardial Infarction and Early Left Ventricular Dysfunction, run by Asklepios proresearch at 1 site in Germany.
Trial summary
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction, Early Left Ventricular Dysfunction
- What is being tested?
- Percutaneous Coronary Intervention and BMNC therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Jan 2014
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI
- conventional therapy according to the ESC guidelines for heart failure
- BMI > 20 and < 35
Who cannot join
- PCI elder then 21 days
- relevant valvular disease
- history of stroke/multivessel disease/thromboembolic event etc.
- DM Type I
- pregancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.
- Being tested
- Percutaneous Coronary Intervention, BMNC therapy
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
common Percutaneous Coronary Intervention
BMNC therapyProcedure or surgery
Injection of BMNC after common PCI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PCI plus BNNC Therapy after acute myocardial infarction Receives: Procedure: BMNC therapy |
| 2 | Active comparator | Percutaneous Coronary Intervention after acute myocardial infarction Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).
Measured: 12 months
Secondary outcomes (2)
Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.
Measured: 12 months
Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.
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 posted14 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepios proresearch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Kuck, MD, PhD, Principal investigator, Asklepios Klinik St. Georg, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939042
- Sponsor's protocol ID
- 1777
- Other IDs
- 2008-004625-42, 2008
- Status last verified
- Oct 2022
- First submitted
- 13 Jul 2009
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells
- ClinicalTrials.gov ID
- NCT00939042
- Acronym / sponsor ID
- 1777
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2009 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Jul 2009 (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.
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: BMNC therapyPCI plus BNNC Therapy after acute myocardial infarction |
| 2 | Active comparator | Procedure: Percutaneous Coronary InterventionPercutaneous Coronary Intervention after acute myocardial infarction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI
- conventional therapy according to the ESC guidelines for heart failure
- BMI > 20 and < 35
Key exclusion criteria (5 listed)
- PCI elder then 21 days
- relevant valvular disease
- history of stroke/multivessel disease/thromboembolic event etc.
- DM Type I
- pregancy
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 |
|---|---|---|
| Percutaneous Coronary Interventioncommon Percutaneous Coronary Intervention | Procedure or surgery | 2 |
| BMNC therapyInjection of BMNC after common PCI | Procedure or surgery | 1 |
Primary outcome
Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).
Time frame: 12 months
2 secondary outcomes
Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.
Time frame: 12 months
Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
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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.
Karl-Heinz Kuck, MD, PhD principal investigator
Asklepios Klinik St. Georg, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention and BMNC therapy in people with Acute Myocardial Infarction and Early Left Ventricular Dysfunction, run by Asklepios proresearch at 1 site in Germany.
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 5 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 6 Oct 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 Germany. 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.
Are results available for this study?
The study was stopped early (reason given: PI left institution). 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?
Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF). (time frame: 12 months). 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 6 Oct 2022.