Congestive Heart FailurePhase 1/2NCT00326989
Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium
A Phase 1/2 study testing intracoronary stem cell therapy in people with Congestive Heart Failure, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- intracoronary stem cell therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteGermany
- Study dates
- May 2006to Dec 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic ischemic heart disease
- Patients with anterior myocardial infarction > 3months
- EF < 50% or NYHA II-IV
- Age 18-80
- Informed consent
Who cannot join
- Ventricular thrombus
- Infarct < 3 months.
- Active infection or fever
- Chronic inflammatory disease (e.g M. Crohn, Rheumatoid Arthritis)
- HIV Infection oder active Hepatitis
- Neoplastic disease w/o complete remission within 5 years
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- Stroke < 3months
- Creatinine > 2 mg/dl
- Relevant Liver disease (GOT > twice the upper limit).
- Anemia (Hemoglobin <10 mg/dl)
- Thrombocytopenia < 100.000/µl
- Allergies to Aspirin, Clopidogrel, Heparin
- History of bleeding disorder
- History of coagulopathy
- Gastrointestinal Bleeding < 3 months
- Surgery or Trauma < 2 months
- Pregnancy
- Mental Retardation
- Participation in other clinical study < 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease
Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction.
Shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy
Read the detailed description
Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)
- Conditions
- Congestive Heart Failure
- Being tested
- intracoronary stem cell therapy
- Keywords
- Extracorporal shock wave therapy, Cell therapy
- 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 stem cell therapyProcedure or surgery
extracorporal shock waves prior to intracoronary cell therapy
| Study group | Role | What they receive |
|---|---|---|
| Low-dose shock wave treatment & Placebo | Active comparator | Not described Receives: Procedure: intracoronary stem cell therapy |
| low-dose shock-wave treatment & Cell therapy | Active comparator | Not described Receives: Procedure: intracoronary stem cell therapy |
| High-dose shock-wave treatment & Placebo | Active comparator | Not described Receives: Procedure: intracoronary stem cell therapy |
| High-dose shock-wave treatment & cell therapy | Active comparator | Not described Receives: Procedure: intracoronary stem cell therapy |
| Placebo shock-wave treatment & cell therapy | Active comparator | Not described Receives: Procedure: intracoronary stem cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in global ejection fraction on LV angiography
Measured: 4 months
Secondary outcomes (5)
Global or regional wall motion at 4 months and 1 year
Measured: 4 months
NYHA Class
Measured: 4 months
NT BNP levels
Measured: 4 months
MACE
Measured: 4 months
Life quality
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startMay 2006
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congestive 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. M. Zeiher, Johann Wolfgang Goethe University Hospital
- Investigators
- Andreas M Zeiher, MD, Principal investigator, Div. of Cardiology, University of Frankfurt, GermanyDirk H Walter, MD, Study director, Div. of Cardiology, University of Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326989
- Sponsor's protocol ID
- 2005-005709-50
- Other IDs
- Cellwave CHF, 2005
- Status last verified
- Mar 2017
- First submitted
- 16 May 2006
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Assmus B, Walter DH, Seeger FH, Leistner DM, Steiner J, Ziegler I, Lutz A, Khaled W, Klotsche J, Tonn T, Dimmeler S, Zeiher AM. Effect of shock wave-facilitated intracoronary cell therapy on LVEF in patients with chronic heart failure: the CELLWAVE randomized clinical trial. JAMA. 2013 Apr 17;309(15):1622-31. doi: 10.1001/jama.2013.3527.
PubMed 23592107Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.
PubMed 22936827
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT00326989
- Acronym / sponsor ID
- 2005-005709-50
- Conditions
- Congestive Heart Failure
- Keywords
- Extracorporal shock wave therapy, Cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 May 2006 (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.
Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction.
Shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy
Detailed description
Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low-dose shock wave treatment & Placebo | Active comparator | Procedure: intracoronary stem cell therapy |
| low-dose shock-wave treatment & Cell therapy | Active comparator | Procedure: intracoronary stem cell therapy |
| High-dose shock-wave treatment & Placebo | Active comparator | Procedure: intracoronary stem cell therapy |
| High-dose shock-wave treatment & cell therapy | Active comparator | Procedure: intracoronary stem cell therapy |
| Placebo shock-wave treatment & cell therapy | Active comparator | Procedure: intracoronary stem cell therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic ischemic heart disease
- Patients with anterior myocardial infarction > 3months
- EF < 50% or NYHA II-IV
- Age 18-80
- Informed consent
Key exclusion criteria (19 listed)
- Ventricular thrombus
- Infarct < 3 months.
- Active infection or fever
- Chronic inflammatory disease (e.g M. Crohn, Rheumatoid Arthritis)
- HIV Infection oder active Hepatitis
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 stem cell therapyextracorporal shock waves prior to intracoronary cell therapy | Procedure or surgery | High-dose shock-wave treatment & Placebo, High-dose shock-wave treatment & cell therapy, Low-dose shock wave treatment & Placebo, Placebo shock-wave treatment & cell therapy, low-dose shock-wave treatment & Cell therapy |
Primary outcome
Improvement in global ejection fraction on LV angiography
Time frame: 4 months
5 secondary outcomes
Global or regional wall motion at 4 months and 1 year
Time frame: 4 months
NYHA Class
Time frame: 4 months
NT BNP levels
Time frame: 4 months
MACE
Time frame: 4 months
Life quality
Time frame: 4 months
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 21 Mar 2017.
- Derived from this study: PubMed 23592107Assmus B, Walter DH, Seeger FH, Leistner DM, Steiner J, Ziegler I, Lutz A, Khaled W, Klotsche J, Tonn T, Dimmeler S, Zeiher AM. Effect of shock wave-facilitated intracoronary cell therapy on LVEF in patients with chronic heart failure: the CELLWAVE randomized clinical trial. JAMA. 2013 Apr 17;309(15):1622-31. doi: 10.1001/jama.2013.3527.
- Derived from this study: PubMed 22936827Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.
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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.
Andreas M Zeiher, MD principal investigator
Div. of Cardiology, University of Frankfurt, Germany
Dirk H Walter, MD study director
Div. of Cardiology, University of Frankfurt
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 stem cell therapy in people with Congestive Heart Failure, run by Johann Wolfgang Goethe University Hospital 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 5 inclusion and 19 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 21 Mar 2017. 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.
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?
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?
Improvement in global ejection fraction on LV angiography (time frame: 4 months). 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 NCT00326989, which also lists 2 linked publications.
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 21 Mar 2017.