Stem Cells and Resynchronization Cardiac

Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00800657

Acronym

RCT and SCT

Enrollment

Registered

2008-12-02

Start date

2008-11-30

Completion date

2011-12-31

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac Resynchronization, Dilated Cardiomyopathy, Stem Cells Therapy, Heart Failure, Stem Cells/Cardiac Pacing, Artificial

Brief summary

Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.

Detailed description

About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.

Interventions

PROCEDUREPacing and Stem Cells Implantations.

Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.

PROCEDUREPacing and Stem Cells Implantation

Pacing and Stem Cells Implantation.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Dilated Cardiomyopathy * Heart Failure * Optimized Therapeutics * Ventricular Desynchrony * Functional Class III or IV * Ejection Fraction(Echo/ Sympson) \< 35%

Design outcomes

Primary

Measure	Time frame
Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.	24 months

Secondary

Measure	Time frame
Ejection Fraction (Echo/Sympson) and functional class(NYHA).	24 months.

Countries

Brazil

Contacts

Primary ContactOswaldo Tadeu Greco, PhD

oswaldogreco@terra.com.br55-17-3203-4000

Backup ContactAna Carolina de Abreu, MD

carolina.cpc@terra.com.br55-17-7811-8477

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026