Ignite Creation Date:
2024-05-05 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00535197
Status:
COMPLETED
Last Update Posted:
2019-07-08
First Post:
2007-09-25
Brief Title:
Autologous Bone Marrow Stem Cells in Ischemic Stroke
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
A Phase III 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
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to determine the safety and tolerability of an autologous CD34 subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome TACSPACS
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None