Autologous Bone Marrow Stem Cells in Ischemic Stroke.

Stroke, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535197
• Other study ID #: HHSC/003
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2007
• Est. completion date: December 2012

Study information

• Verified date: July 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Infarction, Middle Cerebral Artery
• Stroke
• Stroke, Acute

Intervention

Biological:
• Infusion of autologous CD34+ stem cells into middle cerebral artery
intra-arterial infusion into ipsilateral MCA, via trans-femoral approach

Locations

Country	Name	City	State
United Kingdom	St Marys Hospital	Paddington	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Banerjee S, Bentley P, Hamady M, Marley S, Davis J, Shlebak A, Nicholls J, Williamson DA, Jensen SL, Gordon M, Habib N, Chataway J. Intra-Arterial Immunoselected CD34+ Stem Cells for Acute Ischemic Stroke. Stem Cells Transl Med. 2014 Nov;3(11):1322-30. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results	safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results	Duration of study
Secondary	Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale.		Duration of study