Status:
COMPLETED
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
Lead Sponsor:
Hospital Universitario Central de Asturias
Collaborating Sponsors:
Hospitales Universitarios Virgen del Rocío
Conditions:
Stroke, Acute
Infarction, Middle Cerebral Artery
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 cer...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00761982
Start Date
September 1 2008
End Date
August 1 2011
Last Update
November 29 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospitales Universitarios Virgen del Rocío
Seville, Andalusia, Spain
2
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33006