Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy

NCT00743639 | Completed Phase 2 DMC

• 1 other identifier: UP3758
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.

Conditions

Dilated Cardiomyopathy

Keywords

Cardiomyopathy; stem cell; cardiac failure

Outcome Measures

Primary Outcomes (1)

• Increase of the ejection function of the left ventricle

  twelve months

Study Arms (1)

1

OTHER

Interventional

Procedure: intramyocardial bone marrow stem cells implantation

Interventions

intramyocardial bone marrow stem cells implantation PROCEDURE

Control group: the patients will be monitored with regular medical visits. Echocardiography: baseline,3,6,9 months. Cardiac NMR at baseline, 3 and 9 months. Interventional group: Bone-marrow was collected from in the anterior-superior iliac crest and mononuclear stem cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5ml), in the anterior, lateral, posterior and apical faces of the LV ((average 9.6±2.6 x 10\[7\] cells). After the procedure, the patients were kept in the p.o. for a minimum period of 24hrs. They were released from the hospital in a period that varied from 5-7 days.

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis made at more than one year 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 70 years
• Absence of neoplasm
• Abscence of hematologic disease or systemic disease
• No previous cardiac intervention

You may not qualify if:

• Episodes of tachycardia or ventricular fibrillation
• Severe or moderated mitral insufficiency
• Any other valvulopathies
• Previous cardiac surgery

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Institute of Cardiology of Rio Grande do Sul / FUC

Porto Alegre, Rio Grande do Sul, 90620001, Brazil

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Cardiomyopathies; Heart Failure

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Renato AK Kalil, MD, PhD

  Institute of Cardiology of Rio Grande do Sul / FUC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: July 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2008
• Last Updated: August 29, 2008

Record last verified: 2008-06

Locations

BR (1)