Autologous Bone Marrow Stem Cells in Ischemic Stroke.
|Stroke, Acute Infarction, Middle Cerebral Artery||Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Phase I/II Safety and Tolerability Study Following the Autologous Infusion of Immuno-selected CD34+ Subset Bone Marrow Stem Cells Into Patients With Acute Total Anterior Circulation Ischaemic Stroke|
- Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results [ Time Frame: Duration of study ]safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
- Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale. [ Time Frame: Duration of study ]
|Study Start Date:||September 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery
The proposed trial will involve the recruitment of a total of 10 patients.
The cells will be collected from each subject recruited, via bone marrow sampling. CD34+ stem cells will then be isolated and harvested during a process of immuno-selection in accordance with the principles of Good Manufacturing Practice. The CD34+ cells will then be directly infused into the area of the stroke intra-arterially using the middle cerebral artery.
Initially, the investigator will monitor each patient for a period of 6 months post-stem cell infusion. Thereafter, they will revert to their previous treatment regime in the clinic.
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: NCT00535197
|St Marys Hospital|
|Paddington, London, United Kingdom, W2 1NY|
|Principal Investigator:||Nagy Habib, Professor||Imperial College London U.K.|