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Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.

Stroke, Acute Clinical Trial

Official title:
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment

Clinical Trial Summary

The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.

Clinical Trial Description

The proposed trial will involve the recruitment of a total of 20 patients.

The cells will be collected from ten subject recruited as cases, via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, which will be resuspended in heparinized isotonic saline for infusion into the area of the stroke intra-arterially using the middle cerebral artery.

The investigators will monitor each case and control for a period of 6 months post-stem cell infusion. Initially, they will be subjected to a review after one month,three months and finally 6 months.

Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00761982
Study type Interventional
Source Hospital Universitario Central de Asturias
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2008
Completion date August 2011
View Details
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