Clinical Trial: Autologous Bone Marrow Stem Cells in Ischemic Stroke.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 (TACS/PACS).

Detailed Summary:

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.


Sponsor: Imperial College London

Current Primary Outcome: 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


Original Primary Outcome: Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results [ Time Frame: Duration of study ]

Current Secondary Outcome: Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale. [ Time Frame: Duration of study ]

Original Secondary Outcome: Same as current

Information By: Imperial College London

Dates:
Date Received: September 25, 2007
Date Started: September 2007
Date Completion:
Last Updated: February 15, 2016
Last Verified: July 2012