Acute Myocardial InfarctionPhase 1/2CARDIACNCT00437710
Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction
A Phase 1/2 study testing cell therapy, bone marrow derived stem cell in people with Acute Myocardial Infarction, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
Trial summary
We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- cell therapy, bone marrow derived stem cell
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2005to Feb 2007
- 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
- Recent acute transmural anterior myocardial infarction, (in agreement with WHO)
- single left anterior descending coronary artery disease
- <72 hour from the origin of symptoms
- successful primary angioplasty of the culprit lesion
Who cannot join
- screening >72 hours after infarction,
- cardiac shock, severe comorbidity, alcohol or drug dependency
- severe comorbidity (DM,renal or liver insufficiency)
- potential child bearing woman
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
G da Saliceto Hospital
Piacenza, 29100
Massimo Piepoli, MD, +390 523 303217, m.piepoli@ausl.pc.it
Daniele Vallisa, MD, +390 523 303737, d.vallisa@ausl.pc.it
About this study
Official title: Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans
We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy.
After standard therapy for acute MI, 10 patients were transplanted with autologous mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute MI were treated by standard therapy alone. After
Read the detailed description
Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).
- Conditions
- Acute Myocardial Infarction
- Being tested
- cell therapy, bone marrow derived stem cell
- Keywords
- bone marrow, cell transplantation, stem cells, PTCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell therapy, bone marrow derived stem cellProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality and Morbidity
Left ventricular function
Secondary outcomes (5)
Left ventricular remodeling
Heart rate variability
Baroreflex sensitivity
Stress induced myocardial ischemia
Cell dose response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startJul 2005
- Study completionFeb 2007 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Investigators
- Massimo Piepoli, MD, PhD, Principal investigator, G. da Saliceto Hospital, Regional Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437710
- Sponsor's protocol ID
- 01/2007
- Acronym
- CARDIAC
- Status last verified
- Feb 2007
- First submitted
- 20 Feb 2007
- Last updated
- 24 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans
- ClinicalTrials.gov ID
- NCT00437710
- Acronym / sponsor ID
- CARDIAC / 01/2007
- Conditions
- Acute Myocardial Infarction
- Keywords
- bone marrow, cell transplantation, stem cells, PTCA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Feb 2007 (estimated)
- First posted
- 21 Feb 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.
We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy.
After standard therapy for acute MI, 10 patients were transplanted with autologous mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute MI were treated by standard therapy alone. After
Detailed description
Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent acute transmural anterior myocardial infarction, (in agreement with WHO)
- single left anterior descending coronary artery disease
- <72 hour from the origin of symptoms
- successful primary angioplasty of the culprit lesion
Key exclusion criteria (5 listed)
- screening >72 hours after infarction,
- cardiac shock, severe comorbidity, alcohol or drug dependency
- severe comorbidity (DM,renal or liver insufficiency)
- potential child bearing woman
- inability to provide informed consent
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 |
|---|---|---|
| cell therapy, bone marrow derived stem cell | Procedure or surgery | – |
Primary outcome
Mortality
Mortality and Morbidity
Left ventricular function
5 secondary outcomes
Left ventricular remodeling
Heart rate variability
Baroreflex sensitivity
Stress induced myocardial ischemia
Cell dose response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
- Azienda USL Piacenza web siteLink provided by the sponsor.
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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.
Massimo Piepoli, MD, PhD principal investigator
G. da Saliceto Hospital, Regional Health Authority
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 cell therapy, bone marrow derived stem cell in people with Acute Myocardial Infarction, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 24 Mar 2010. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Piepoli, MD, PhD (+390 523 303217, m.piepoli@ausl.pc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality. The study lists 3 primary outcomes in all. 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 24 Mar 2010.