Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.

Phase 1

Completed

• Conditions: Stroke, Acute; Infarction, Middle Cerebral Artery
• Interventions: Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery

• Registration Number: NCT00761982
• Lead Sponsor: Hospital Universitario Central de Asturias

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 month,three 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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-28
• Study First Submitted QC: 2008-09-28
• Study First Posted: 2008-09-30
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-27
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Symptoms and signs of clinically definite middle cerebral artery acute stroke.
• Time of stroke onset is known and treatment can be started between day 5 and 9 of onset.
• DWI-MRI has reliably shown relevant acute ischemic lesions
• Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability.
• The stroke is severe (NIH Stroke Scale >= 8 before procedure).
• An age range of 18-80 years old.

Exclusion Criteria

• Patients out of inclusion age range.
• Lacunar infarction.
• Patients with cancer.
• Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma.
• Hematological 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.
• Patient is likely to be unavailable for follow-up.
• Patient with evidence of life threatening infection of life threatening illness.
• Patient was already dependent in activities of daily living before the present acute stroke.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bone marrow stem cells	Infusion on autologous CD34+ stem cells into middle cerebral artery	Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery.

Primary Outcome Measures

Name	Time	Method
Absence of new neurological deficits and adverse effects during the timeframe.	Duration of study

Secondary Outcome Measures

Name	Time	Method
Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale.	Duration of study

Trial Locations

Locations (2)

Hospitales Universitarios Virgen del Rocío; 🇪🇸 Sevilla, Andalucia, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain