Autologous Bone Marrow Stem Cells in Ischemic Stroke.
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|ClinicalTrials.gov Identifier: NCT00535197|
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute Infarction, Middle Cerebral Artery||Biological: Infusion of autologous CD34+ stem cells into middle cerebral artery||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Actual Study Start Date :||September 2007|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||December 2012|
Experimental: CD34+ stem/progenitor cell therapy
Patients presenting within 7 days of onset with severe anterior circulation ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score≥8). CD34+ cells were collected from the bone marrow of the subjects before being delivered by catheter angiography into the ipsilesional middle cerebral artery.
Biological: Infusion of autologous CD34+ stem cells into middle cerebral artery
intra-arterial infusion into ipsilateral MCA, via trans-femoral approach
- 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 ]
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): NCT00535197
|St Marys Hospital|
|Paddington, London, United Kingdom, W2 1NY|
|Principal Investigator:||Nagy Habib, Professor||Imperial College London U.K.|