Autologous Bone Marrow Stem Cells in Ischemic Stroke.

Sponsor

Imperial College London (Other)

Overall Status

Completed

CT.gov ID

NCT00535197

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

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 :

Sep 1, 2007

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results [Duration of study]
safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results

Secondary Outcome Measures

Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale. [Duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Symptoms and signs of clinically definite acute stroke
Time of stroke onset is known and treatment can be started within 7 days of onset
CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
The stroke is severe and conforming to the TACS phenotype (weakness, homonymous hemianopia and a focal cognitive deficit (e.g. aphasia) or reduction in consciousness) or PACS phenotype (two out of the three TACS criteria)
An age range of 30-80 years old
Stroke confined to MCA territory on CT or MRI brain imaging
NIHSS score >/= 8

Exclusion Criteria:

Known defect of clotting or platelet function (but patients on anti-platelet agents can enrol)
Haematological causes of stroke
Severe co-morbidity
Hepatic or renal dysfunction
The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is < 3.0 or > 20.0mmol/L
Patient is likely to be unavailable for follow-up e.g. no fixed home address
Patients with evidence of life threatening infection (e.g. HIV) or life threatening illness (e.g. advanced cancer)
Patient was already dependent in activities of daily living before the present acute stroke
Patients who have been included in any other clinical trial within the previous month