Cell Therapy in Dilated Cardiomyopathy: Observational Study | NCT00612911

Studies
Cell Therapy in Dilated Cardiomyopathy: Observational Study

NCT00612911

Sponsor

Ministry of Health, Brazil

Status

Terminated

Last Update Posted

Feb 12, 2008Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Cardiomyopathy, Dilated

Interventions

Cell therapy

Countries

Brazil

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

Jan 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

finish study as protocol

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2007Actual

First Submitted Date

Jan 23, 2008

First Submission Date that Met QC Criteria

Jan 29, 2008

First Posted Date

Feb 12, 2008Estimated

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

Jan 29, 2008

Last Update Posted Date

Feb 12, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy

Detailed Description

Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction <35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Major group		Patients with Idiopathic dilated cardiomyopathy	Other: Cell therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cell therapy	Other	bone marrow mononuclear cell	Major group

Measure	Description	Time Frame
echocardiography		2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of idiopathic dilated cardiomyopathy
Optimized therapy and for idiopathic dilated cardiomyopathy
Left ventricular ejection fraction (Simpson) < 35%
Peak oxygen consumption (VO2 peak) < 16 mL.kg-1min-1
Functional classes II-IV of the NYHA

Exclusion Criteria:

dilated cardiopathies of ischemic or chagasic origin
primary valve disease
excessive use of alcohol or illicit drugs
pregnancy
ventricular arrhythmias
any co-morbidity with impact on survival

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with idiopathic dilated cardiomyopathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helena F Martino	Brazil: National Insittute of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INCL - National Institute of Cardiology Laranjeiras		Rio de Janeiro	Rio de Janeiro	22.240-006	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D002311	Cardiomyopathy, Dilated

Ancestor Terms

ID	Term
D006332	Cardiomegaly
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009202	Cardiomyopathies

Browse Leaves

Not provided

Browse Branches

Not provided

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