Safety and Efficacy of Bone Marrow Cell Transplantation i... | NCT00437710

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

NCT00437710

Sponsor

Azienda Unita Sanitaria Locale di Piacenza

Status

Unknown status

Last Update Posted

Mar 24, 2010Estimated

Enrollment

50Estimated

Phase

Phase 1Phase 2

Conditions

Acute Myocardial Infarction

Interventions

cell therapy, bone marrow derived stem cell

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Feb 2007Estimated

First Submitted Date

Feb 20, 2007

First Submission Date that Met QC Criteria

Feb 20, 2007

First Posted Date

Feb 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2010

Last Update Posted Date

Mar 24, 2010Estimated

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
cell therapy, bone marrow derived stem cell	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality
Mortality and Morbidity
Left ventricular function

Secondary Outcomes

Measure	Description	Time Frame
Left ventricular remodeling
Heart rate variability
Baroreflex sensitivity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Massimo Piepoli, MD, PhD	Contact	+390 523 303217		m.piepoli@ausl.pc.it
Daniele Vallisa, MD	Contact	+390 523 303737		d.vallisa@ausl.pc.it

Overall Officials

Name	Affiliation	Role
Massimo Piepoli, MD, PhD	G. da Saliceto Hospital, Regional Health Authority	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
G da Saliceto Hospital	Recruiting	Piacenza		29100	Italy

Label	URL
Azienda USL Piacenza web site	View source

Intervention Browse Module

MeSH Terms

ID	Term
D064987	Cell- and Tissue-Based Therapy

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided