Acute Myocardial InfarctionPhase 1/2NCT00400959
CD133+ Autologous Cells After Myocardial Infarction
A Phase 1/2 study testing cd133+cell intracoronary administration in people with Acute Myocardial Infarction, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction. TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group. SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- cd133+cell intracoronary administration
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2004to Oct 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent;
- age: 18-65 years;
- large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms;
- signs of microvascular dysfunction in the infarcted area: absence of STeR and angiographic MB, graded according to the dye density score (see van't Hof et al., Circulation, 1998); life expectancy more than 6 months.
Who cannot join
- Pregnancy;
- indication to aorto-coronaric by-pass;
- neoplasia (previous or in progress);
- primary diseases of the BM;
- diabetes;
- immunosuppressive therapy;
- laboratory alterations of protein S, protein C, ATIII or Fibrinogen;
- severe co-morbidity.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Cell Factory, department of regenerative medicine, Policlinic of Milan
Milan
About this study
Official title: Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction
TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.
TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.
Read more
SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).
OBJECTIVES Primary:
- To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
- To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls. Secondary:
- To evaluate the disease-related morbility of the target population.
- Conditions
- Acute Myocardial Infarction
- Being tested
- cd133+cell intracoronary administration
- Keywords
- cell therapy, acute myocardial infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cd133+cell intracoronary administrationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
Ejection fraction (%) evaluated by 2D echocardiography;
Secondary outcomes (2)
perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startJun 2004
- Study completionOct 2006
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 Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- 15 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Rosaria Giordano, MD, Principal investigator, Cell Factory Department of Regenerative Medicine Policlinic Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400959
- Sponsor's protocol ID
- CFT92002
- Status last verified
- Nov 2006
- First submitted
- 14 Nov 2006
- Last updated
- 17 Nov 2006
- Results posted
- No
Publications
Colombo A, Castellani M, Piccaluga E, Pusineri E, Palatresi S, Longari V, Canzi C, Sacchi E, Rossi E, Rech R, Gerundini P, Viecca M, Deliliers GL, Rebulla P, Soligo D, Giordano R. Myocardial blood flow and infarct size after CD133+ cell injection in large myocardial infarction with good recanalization and poor reperfusion: results from a randomized controlled trial. J Cardiovasc Med (Hagerstown). 2011 Apr;12(4):239-48. doi: 10.2459/JCM.0b013e328343d708.
PubMed 21372740
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00400959
- Acronym / sponsor ID
- CFT92002
- Conditions
- Acute Myocardial Infarction
- Keywords
- cell therapy, acute myocardial infarction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Oct 2006
- First posted
- 17 Nov 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.
TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.
TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.
SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).
OBJECTIVES Primary:
- To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
- To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls. Secondary:
- To evaluate the disease-related morbility of the target population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent;
- age: 18-65 years;
- large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms;
- signs of microvascular dysfunction in the infarcted area: absence of STeR and angiographic MB, graded according to the dye density score (see van't Hof et al., Circulation, 1998); life expectancy more than 6 months.
Key exclusion criteria (8 listed)
- Pregnancy;
- indication to aorto-coronaric by-pass;
- neoplasia (previous or in progress);
- primary diseases of the BM;
- diabetes;
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 |
|---|---|---|
| cd133+cell intracoronary administration | Procedure or surgery | – |
Primary outcome
myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
Ejection fraction (%) evaluated by 2D echocardiography;
2 secondary outcomes
perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D
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 17 Nov 2006.
- Derived from this study: PubMed 21372740Colombo A, Castellani M, Piccaluga E, Pusineri E, Palatresi S, Longari V, Canzi C, Sacchi E, Rossi E, Rech R, Gerundini P, Viecca M, Deliliers GL, Rebulla P, Soligo D, Giordano R. Myocardial blood flow and infarct size after CD133+ cell injection in large myocardial infarction with good recanalization and poor reperfusion: results from a randomized controlled trial. J Cardiovasc Med (Hagerstown). 2011 Apr;12(4):239-48. doi: 10.2459/JCM.0b013e328343d708.
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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.
Rosaria Giordano, MD principal investigator
Cell Factory Department of Regenerative Medicine Policlinic Milan
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 cd133+cell intracoronary administration in people with Acute Myocardial Infarction, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 8 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 17 Nov 2006. 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?
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?
myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),. The study lists 2 primary outcomes in all. 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 NCT00400959, 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 17 Nov 2006.