NCT00535197

Autologous Bone Marrow Stem Cells in Ischemic Stroke.

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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 (TACS/PACS).

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.

Conditions

• Stroke, Acute
• Infarction, Middle Cerebral Artery

Interventions

Type	Name	Description
BIOLOGICAL	Infusion of autologous CD34+ stem cells into middle cerebral artery	intra-arterial infusion into ipsilateral MCA, via trans-femoral approach

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-07-01
• Completion: 2012-12-01
• First posted: 2007-09-26
• Last updated: 2019-07-08

Locations

1 site across 1 country: United Kingdom