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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.

Sponsor: Hospital Universitario Central de Asturias

Current Primary Outcome: Absence of new neurological deficits and adverse effects during the timeframe. [ Time Frame: Duration of study ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale. [ Time Frame: Duration of study ]

Original Secondary Outcome: Same as current

Information By: Hospital Universitario Central de Asturias

Dates:
Date Received: September 28, 2008
Date Started: September 2008
Date Completion:
Last Updated: November 27, 2011
Last Verified: November 2011