Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
|ClinicalTrials.gov Identifier: NCT00761982|
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : November 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute Infarction, Middle Cerebral Artery||Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761982
|Hospitales Universitarios Virgen del Rocío|
|Sevilla, Andalucia, Spain|
|Hospital Universitario Central de Asturias|
|Oviedo, Asturias, Spain, 33006|