CClinicalTrials.gg
Status unknownNCT00437710CARDIACUpdated Mar 24, 2010

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

A Phase 1/2 interventional study of cell therapy, bone marrow derived stem cell in Acute Myocardial Infarction, sponsored by Azienda Unita Sanitaria Locale di Piacenza. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-03-24.

Sponsored by Azienda Unita Sanitaria Locale di Piacenza · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the detailed description

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

02

Conditions studied

  • Acute Myocardial Infarction

Keywords

  • bone marrow, cell transplantation, stem cells, PTCA
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 50 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Azienda Unita Sanitaria Locale di Piacenza is the lead sponsor of 15 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • Procedurecell therapy, bone marrow derived stem cell
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What researchers measure

Primary outcomes

  1. Mortality

  2. Mortality and Morbidity

  3. Left ventricular function

Secondary outcomes

  1. Left ventricular remodeling

  2. Heart rate variability

  3. Baroreflex sensitivity

  4. Stress induced myocardial ischemia

  5. Cell dose response

07

Study locations

1 of 1 sites recruiting
  • G da Saliceto Hospital
    Piacenza, 29100, Italy
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00437710
Lead sponsor
Azienda Unita Sanitaria Locale di Piacenza
First posted
Feb 21, 2007
Start date
Jul 2005
Completion
Feb 2007 (estimated)
Last update
Mar 24, 2010

Study contacts

Massimo Piepoli, MD, PhD
Contact
m.piepoli@ausl.pc.it
+390 523 303217
Daniele Vallisa, MD
Contact
d.vallisa@ausl.pc.it
+390 523 303737
Massimo Piepoli, MD, PhD
principal investigator · G. da Saliceto Hospital, Regional Health Authority
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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