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

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761982
• Other study ID #: OVISEV-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 28, 2008
• Last updated: November 27, 2011
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Hospital Universitario Central de Asturias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Infusion on autologous CD34+ stem cells into middle cerebral artery
Intraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospitales Universitarios Virgen del Rocío	Sevilla	Andalucia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Central de Asturias	Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of new neurological deficits and adverse effects during the timeframe.		Duration of study	Yes
Secondary	Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale.		Duration of study	Yes