Heart DiseaseAlster-StarNCT01144221
Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy
A study testing Intramyocardial Cell therapy in people with Heart Disease, run by Kai Jaquet, PhD, DSc at 1 site in Germany.
Trial summary
This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Disease
- What is being tested?
- Intramyocardial Cell therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Feb 2015
- 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
- chronic left ventricular dysfunction (ejection fraction <35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of >15% of LVEF 3 months after CRT-device implantation
- wall motion dysfunction of any territory
- left bundle branch block
- Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation
Who cannot join
- patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy
- with relevant valvular disease;
- Aneurysma of the anterior myocardial wall or myocardial wall thickness of < 5 mm,
- with overt heart failure, other than ischemic cardiomyopathy,
- with history of stroke and/or transient ischemic attack (TIA),
- with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system;
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- with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment;
- with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against X-ray or contrast agent and, pre-malignant and malignant disease)
- atrial fibrillation with average heart rate >70 bpm
- pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment;
- with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results;
- patients with a chronic or acute HIV-, HBV-, HCV-infection;
- improvement of more than 15% of LVEF 3 months after CRT-device implantation
- patients who have a ICD Implantation for secondary prophylactic indication. These patients show a history of resuscitation, VT or syncope.
- patients who are currently participating in another investigational drug or device study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol on an Evaluative Study on Bone Marrow Derived Mononuclear Cells for Optimization of Biventricular Pacing in Patients With Chronic Ischemic Left Ventricular Dysfunction
This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.
- Conditions
- Heart Disease
- Being tested
- Intramyocardial Cell therapy
- Keywords
- Chronic Ischemic Heart Disease
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramyocardial Cell therapyProcedure or surgery
Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation
| Study group | Role | What they receive |
|---|---|---|
| Stem cell treatment | Experimental | Patients treated via stem cell injection Receives: Procedure: Intramyocardial Cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVEF Value
LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection
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 posted15 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionFeb 2015
Why it stopped: funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kai Jaquet, PhD, DSc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Kai Jaquet, PhD, DSc, Asklepios proresearch
- Investigators
- Korff Krause, Dr. med., Principal investigator, Asklepios proresearch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144221
- Sponsor's protocol ID
- 1764
- Other IDs
- 2008-008368-28, 2008
- Acronym
- Alster-Star
- Status last verified
- Aug 2012
- First submitted
- 14 Jun 2010
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol on an Evaluative Study on Bone Marrow Derived Mononuclear Cells for Optimization of Biventricular Pacing in Patients With Chronic Ischemic Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT01144221
- Acronym / sponsor ID
- Alster-Star / 1764
- Conditions
- Heart Disease
- Keywords
- Chronic Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding issues
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kai Jaquet, PhD, DScIndustry (pharma, biotech, devices)
- Study start
- May 2010 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Jun 2010 (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 is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cell treatment | Experimental | Procedure: Intramyocardial Cell therapyPatients treated via stem cell injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic left ventricular dysfunction (ejection fraction <35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of >15% of LVEF 3 months after CRT-device implantation
- wall motion dysfunction of any territory
- left bundle branch block
- Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation
Key exclusion criteria (15 listed)
- patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy
- with relevant valvular disease;
- Aneurysma of the anterior myocardial wall or myocardial wall thickness of < 5 mm,
- with overt heart failure, other than ischemic cardiomyopathy,
- with history of stroke and/or transient ischemic attack (TIA),
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 |
|---|---|---|
| Intramyocardial Cell therapyIntramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation | Procedure or surgery | Stem cell treatment |
Primary outcome
LVEF Value
Time frame: 12 months
LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection
Results and safety
The study was stopped early (reason given: funding issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
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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.
Korff Krause, Dr. med. principal investigator
Asklepios proresearch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramyocardial Cell therapy in people with Heart Disease, run by Kai Jaquet, PhD, DSc 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 4 inclusion and 15 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 9 Apr 2018. 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: funding issues). 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?
LVEF Value (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 9 Apr 2018.