Congestive Heart Failure Surgical Treatmment With Autolog... | NCT00480961

Studies
Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

NCT00480961

Sponsor

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Status

Unknown status

Last Update Posted

Jun 1, 2007Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Congestive Heart Failure

Interventions

intramiocardiac autograft of autologous stem cells

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

May 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

May 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 31, 2007

First Submission Date that Met QC Criteria

May 31, 2007

First Posted Date

Jun 1, 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

May 31, 2007

Last Update Posted Date

Jun 1, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The Mediterranean Institute for Transplantation and Advanced Specialized TherapiesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.

Detailed Description

Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
intramiocardiac autograft of autologous stem cells	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.		1 YEAR

Secondary Outcomes

Measure	Description	Time Frame
Secondary target: determine clinical effects of grafted cells on remodeling pathology.		1 YEAR

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Age >18 y/o
CHF with EF > 35%
Bilirubinemia, serum transaminase> 2.5 times normal max level
Creatininemia > 2.5 times max level
NYHA Class > 3
Negative pregnancy test (for women in fertile age)

Exclusion criteria

Impossibility to harvest the bone marrow
Pregnancy or breast-feeding
History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas)
Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
cesare scardulla, MD	Contact	0912192284		cscardulla@ISMETT.edu

Overall Officials

Name	Affiliation	Role
CESARE SCARDULLA, md	The Mediterranean Institute for Transplantation and Advanced Specialized Therapies	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ismett	Recruiting	Palermo	pa	90127	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided