Status:
COMPLETED
CD133+ Autologous Cells After Myocardial Infarction
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00400959
Start Date
June 1 2004
End Date
October 1 2006
Last Update
November 17 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cell Factory, department of regenerative medicine, Policlinic of Milan
Milan, Italy