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

NCT ID: NCT00437710

Last Updated: 2010-03-24

Study Results

Results pending

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.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cell therapy, bone marrow derived stem cell

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Unita Sanitaria Locale di Piacenza

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Massimo Piepoli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

G. da Saliceto Hospital, Regional Health Authority

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

G da Saliceto Hospital

Piacenza, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Massimo Piepoli, MD, PhD

Role: CONTACT

+390 523 303217

Daniele Vallisa, MD

Role: CONTACT

+390 523 303737

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Massimo Piepoli, MD

Role: primary

+390 523 303217

Daniele Vallisa, MD

Role: backup

+390 523 303737

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ausl.pc.it/

Azienda USL Piacenza web site

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01/2007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bone Marrow Cells in Myocardial Infarction
NCT00363324 COMPLETED PHASE2/PHASE3
CD133+ Autologous Cells After Myocardial Infarction
NCT00400959 COMPLETED PHASE1/PHASE2