Myocardial IschemiaPhase 2NCT00235417
Stem Cell Therapy in Chronic Ischemic Heart Failure
A Phase 2 study testing Bone marrow transplantation in people with Myocardial Ischemia and Heart Failure, Congestive, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether intracoronary bone marrow transplantation can improve left ventricular ejection fraction in patients with severe ischemic heart failure and no other option for standard therapies (revascularization and drugs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Ischemia, Heart Failure, Congestive
- What is being tested?
- Bone marrow transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2005to May 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe ischemic heart failure and no other other option for standard therapies (revascularization and drugs),
- Stable left ventricular ejection fraction < 40%,
- CCS class 2-3 and/or NYHA class 2-3, and
- Signed informed consent.
Who cannot join
- Implantation of pacemaker (including implantable cardioverter defibrillator [ICD] and biventricular pacing),
- Acute myocardial infarction within 3 months,
- Atrial fibrillation, or
- Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Odense University Hospital
Odense, Odense C, DK-5000
About this study
The purpose of this study is to determine whether intracoronary bone marrow transplantation can improve left ventricular ejection fraction in patients with severe ischemic heart failure and no other option for standard therapies (revascularization and drugs).
Read the detailed description
Despite standard therapies (revascularization and drugs), patients with severe ischemic heart failure have a high morbidity and mortality.
The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with severe ischemic heart failure.
35 patients with stable left ventricle function will - with four months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories. Echocardiography is performed three times prior (four and two months and just before) and two times after (four and eight months after) therapy. It is a non-randomised trial, patients will enter as their own control.
- Conditions
- Myocardial Ischemia, Heart Failure, Congestive
- Being tested
- Bone marrow transplantation
- Keywords
- Bone Marrow Transplantation
- Medical subject headings
- Myocardial Ischemia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startOct 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Per Thayssen, MDSci, Study director, Department of Cardiology, Odense University HospitalAxel CP Diederichsen, phd, Principal investigator, Department of Cardiology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235417
- Sponsor's protocol ID
- Stem cell
- Status last verified
- Jun 2007
- First submitted
- 6 Oct 2005
- Last updated
- 8 Jun 2007
- Results posted
- No
Publications
Diederichsen AC, Moller JE, Thayssen P, Videbaek L, Saekmose SG, Barington T, Kassem M. Changes in left ventricular filling patterns after repeated injection of autologous bone marrow cells in heart failure patients. Scand Cardiovasc J. 2010 Jun;44(3):139-45. doi: 10.3109/14017430903556294.
PubMed 20233136
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell Therapy in Chronic Ischemic Heart Failure
- ClinicalTrials.gov ID
- NCT00235417
- Acronym / sponsor ID
- Stem cell
- Conditions
- Myocardial Ischemia, Heart Failure, Congestive
- Keywords
- Bone Marrow Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- May 2007 (actual)
- First posted
- 10 Oct 2005 (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 purpose of this study is to determine whether intracoronary bone marrow transplantation can improve left ventricular ejection fraction in patients with severe ischemic heart failure and no other option for standard therapies (revascularization and drugs).
Detailed description
Despite standard therapies (revascularization and drugs), patients with severe ischemic heart failure have a high morbidity and mortality.
The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with severe ischemic heart failure.
35 patients with stable left ventricle function will - with four months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories. Echocardiography is performed three times prior (four and two months and just before) and two times after (four and eight months after) therapy. It is a non-randomised trial, patients will enter as their own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Severe ischemic heart failure and no other other option for standard therapies (revascularization and drugs),
- Stable left ventricular ejection fraction < 40%,
- CCS class 2-3 and/or NYHA class 2-3, and
- Signed informed consent.
Key exclusion criteria (4 listed)
- Implantation of pacemaker (including implantable cardioverter defibrillator [ICD] and biventricular pacing),
- Acute myocardial infarction within 3 months,
- Atrial fibrillation, or
- Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)
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 |
|---|---|---|
| Bone marrow transplantation | Procedure or surgery | – |
Primary outcome
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2007.
- Derived from this study: PubMed 20233136Diederichsen AC, Moller JE, Thayssen P, Videbaek L, Saekmose SG, Barington T, Kassem M. Changes in left ventricular filling patterns after repeated injection of autologous bone marrow cells in heart failure patients. Scand Cardiovasc J. 2010 Jun;44(3):139-45. doi: 10.3109/14017430903556294.
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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.
Per Thayssen, MDSci study director
Department of Cardiology, Odense University Hospital
Axel CP Diederichsen, phd principal investigator
Department of Cardiology, Odense 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 study testing Bone marrow transplantation in people with Myocardial Ischemia and Heart Failure, Congestive, run by Odense University Hospital at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 8 Jun 2007. 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 Denmark. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up. 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 NCT00235417, which also lists 1 linked publication.
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 8 Jun 2007.