Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction (CARDIAC)

Azienda Unità Sanitaria Locale di Piacenza

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Acute Myocardial Infarction

Treatments: Procedure: cell therapy, bone marrow derived stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT00437710

01/2007

Details and patient eligibility

About

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

Full description

Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)