Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2004-06-30
2006-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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:
1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
2. 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:
3. To evaluate the disease-related morbility of the target population.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cd133+cell intracoronary administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rosaria Giordano, MD
Role: PRINCIPAL_INVESTIGATOR
Cell Factory Department of Regenerative Medicine Policlinic Milan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cell Factory, department of regenerative medicine, Policlinic of Milan
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CFT92002
Identifier Type: -
Identifier Source: org_study_id