Ventricular DysfunctionPhase 1TABMMINCT00507468
Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
A Phase 1 study testing Transendocaridal Transplantation of Autologous Bone Marrow in people with Ventricular Dysfunction and Myocardial Infarction, run by BioCardia, Inc. at 2 sites in Argentina.
Trial summary
The object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle transendocardial (TE) delivery system in stable coronary patients with ventricular dysfunction due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Dysfunction, Myocardial Infarction
- What is being tested?
- Transendocaridal Transplantation of Autologous Bone Marrow
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesArgentina
- Study dates
- Dec 2005to Aug 2009
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years of age or older
- Able to give informed consent
- Must have documentation of prior myocardial infarction with left ventricular ejection fraction of less than 40 percent at baseline
- Must be a candidate for percutaneous heart catheterization
- Must have identifiable area of transmural scar within the left ventricle
Who cannot join
- Be a candidate for concurrent ventricular surgical restoration, AICD placement or valvular surgery
- Clinical evidence of infection
- Other complicating cardiovascular abnormalities
- Clinically significant electrocardiographic abnormalities
- Active malignancy
- Recent history or drug or alcohol abuse
Show all 10Show fewer
- Pregnancy, planned or current
- Artificial aortic valve
- Ejection fraction less than 30 percent at baseline
- Myocardial infarction in the past 4 weeks
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites
Swiss Clinic
Buenos Aires, 1118
Argentine Institute of Diagnosis and Treatment
Buenos Aires, 1122
About this study
The object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle transendocardial (TE) delivery system in stable coronary patients with ventricular dysfunction due to chronic myocardial infarction (MI).
A secondary goal was to assess the possibility that such cell injections could improve ejection fraction (EF).
- Conditions
- Ventricular Dysfunction, Myocardial Infarction
- Being tested
- Transendocaridal Transplantation of Autologous Bone Marrow
- Keywords
- bone marrow, autologous, ejection fraction, left ventricle, heart attack, myocardial infarction, left ventricular dysfunction post myocardial infarction
- Medical subject headings
- Ventricular Dysfunction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transendocaridal Transplantation of Autologous Bone MarrowProcedure or surgery
Single treatment, harvest and transplant of patients own bone marrow. Cells are delivered to the myocardium via transendocardial delivery catheter.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startDec 2005
- Primary completionMar 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular DysfunctionStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCardia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luis de la Fuente, MD, Principal investigator, Argentine Institute of Diagnosis and Treatment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507468
- Sponsor's protocol ID
- ABM-MI-10
- Acronym
- TABMMI
- Status last verified
- Nov 2009
- First submitted
- 22 Jul 2007
- Last updated
- 3 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
- ClinicalTrials.gov ID
- NCT00507468
- Acronym / sponsor ID
- TABMMI / ABM-MI-10
- Conditions
- Ventricular Dysfunction, Myocardial Infarction
- Keywords
- bone marrow, autologous, ejection fraction, left ventricle, heart attack, myocardial infarction, left ventricular dysfunction post myocardial infarction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BioCardia, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Jul 2007 (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 object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle transendocardial (TE) delivery system in stable coronary patients with ventricular dysfunction due to chronic myocardial infarction (MI).
A secondary goal was to assess the possibility that such cell injections could improve ejection fraction (EF).
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be 18 years of age or older
- Able to give informed consent
- Must have documentation of prior myocardial infarction with left ventricular ejection fraction of less than 40 percent at baseline
- Must be a candidate for percutaneous heart catheterization
- Must have identifiable area of transmural scar within the left ventricle
Key exclusion criteria (10 listed)
- Be a candidate for concurrent ventricular surgical restoration, AICD placement or valvular surgery
- Clinical evidence of infection
- Other complicating cardiovascular abnormalities
- Clinically significant electrocardiographic abnormalities
- Active malignancy
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 |
|---|---|---|
| Transendocaridal Transplantation of Autologous Bone MarrowSingle treatment, harvest and transplant of patients own bone marrow. Cells are delivered to the myocardium via transendocardial delivery catheter. | Procedure or surgery | – |
Primary outcome
Safety of treatment
Time frame: 6 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 3 Nov 2009.
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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.
Luis de la Fuente, MD principal investigator
Argentine Institute of Diagnosis and Treatment
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transendocaridal Transplantation of Autologous Bone Marrow in people with Ventricular Dysfunction and Myocardial Infarction, run by BioCardia, Inc. at 2 sites in Argentina.
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 10 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 3 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. 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 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.
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?
Safety of treatment (time frame: 6 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 3 Nov 2009.