Ignite Creation Date:
2024-05-05 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00761982
Status:
COMPLETED
Last Update Posted:
2011-11-29
First Post:
2008-09-28
Brief Title:
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment
Sponsor:
Hospital Universitario Central de Asturias
Organization:
Hospital Universitario Central de Asturias
Study Overview
Official Title:
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment
Status:
COMPLETED
Status Verified Date:
2011-11
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 efficacy on an autologous CD34 subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke
Detailed Description:
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 monththree 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
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 monththree 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None