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

Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00437710

Acronym

CARDIAC

Enrollment

Registered

2007-02-21

Start date

2005-07-31

Completion date

2007-02-28

Last updated

2010-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

bone marrow, cell transplantation, stem cells, PTCA

Brief 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. 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).

Interventions

PROCEDUREcell therapy, bone marrow derived stem cell

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Mortality	—
Mortality and Morbidity	—
Left ventricular function	—

Secondary

Measure	Time frame
Stress induced myocardial ischemia	—
Left ventricular remodeling	—
Cell dose response	—
Heart rate variability	—
Baroreflex sensitivity	—

Countries

Italy

Contacts

Primary ContactMassimo Piepoli, MD, PhD

m.piepoli@ausl.pc.it+390 523 303217

Backup ContactDaniele Vallisa, MD

d.vallisa@ausl.pc.it+390 523 303737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026