NCT00437710

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
Last Updated

March 24, 2010

Status Verified

February 1, 2007

First QC Date

February 20, 2007

Last Update Submit

March 23, 2010

Conditions

Acute Myocardial Infarction

Keywords

bone marrow, cell transplantation, stem cells, PTCA

Outcome Measures

Primary Outcomes (3)

  • Mortality

  • Mortality and Morbidity

  • Left ventricular function

Secondary Outcomes (5)

  • Left ventricular remodeling

  • Heart rate variability

  • Baroreflex sensitivity

  • Stress induced myocardial ischemia

  • Cell dose response

Interventions

cell therapy, bone marrow derived stem cellPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G da Saliceto Hospital

Piacenza, 29100, Italy

RECRUITING

Related Links

MeSH Terms

Interventions

Cell- and Tissue-Based Therapy

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Massimo Piepoli, MD, PhD

    G. da Saliceto Hospital, Regional Health Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Piepoli, MD, PhD

CONTACT

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

Daniele Vallisa, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

July 1, 2005

Study Completion

February 1, 2007

Last Updated

March 24, 2010

Record last verified: 2007-02

Locations

IT(1)