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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00615394
Other study ID # UP3549/04
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 1, 2008
Last updated February 1, 2008
Start date April 2004
Est. completion date December 2006

Study information

Verified date February 2008
Source Instituto de Cardiologia do Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority Brasil:CONEP, National Ethical Committee
Study type Interventional

Clinical Trial Summary

Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date December 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy

- left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram

- age below 60 years

- absence of neoplasm

- absence of hematologic disease or systemic disease

- no previous cardiac intervention

Exclusion Criteria:

- episodes of tachycardia or ventricular fibrillation

- severe or moderated mitral insufficiency

- any other valvulopathies

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
intramyocardial bone marrow stem cells implantation
Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.

Locations

Country Name City State
Brazil Instituto de Cardiologia do Rio Grande do Sul Porto Alegre RS

Sponsors (3)

Lead Sponsor Collaborator
Instituto de Cardiologia do Rio Grande do Sul Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary safety: morbidity/mortality eighteen months Yes
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