Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
|Stroke, Acute Infarction, Middle Cerebral Artery||Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment|
- Absence of new neurological deficits and adverse effects during the timeframe. [ Time Frame: Duration of study ]
- Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale. [ Time Frame: Duration of study ]
|Study Start Date:||September 2008|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
bone marrow stem cells
Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery.
Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery
Intraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761982
|Hospitales Universitarios Virgen del Rocío|
|Sevilla, Andalucia, Spain|
|Hospital Universitario Central de Asturias|
|Oviedo, Asturias, Spain, 33006|