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Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy

Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00615394
Acronym
STEMDILCARD
Enrollment
6
Registered
2008-02-14
Start date
2004-04-30
Completion date
2006-12-31
Last updated
2008-02-14

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

Conditions

Dilated Cardiomyopathy

Keywords

cardiomyopathy, stem cell, cardiac failure

Brief 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.

Interventions

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.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
safety: morbidity/mortalityeighteen months

Countries

Brazil

Outcome results

None listed

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