Status:
COMPLETED
Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke
Lead Sponsor:
Universidade Federal do Rio de Janeiro
Collaborating Sponsors:
Ministry of Science and Technology, Brazil
Ministry of Health, Brazil
Conditions:
Infarction, Middle Cerebral Artery
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a open label study to assess the safety of autologous bone marrow transplantation in patients with a ischemic stroke in the middle cerebral artery territory within 90 days from symptoms onset.
Detailed Description
Objective: The purpose of this study is to evaluate the safety and feasibility of intra-arterial and intravenous injection of autologous bone marrow mononuclear cells in patients in the acute and sub-...
Eligibility Criteria
Inclusion
- clinical diagnosis of ischemic stroke lasting for more than 3 hours and less than 90 days from symptoms onset
- neuroimages exams showing ischemic cerebral infarct in the middle cerebral artery territory
- age between 18 and 75 years old
- NIHSS between 4 and 20
- spontaneous re-canalization of the middle cerebral artery documented by TCD or MRI
- signed informed consent
Exclusion
- difficult in obtaining vascular access for percutaneous procedures
- vascular impossibility to reach the middle cerebral artery through percutaneous approach
- severe carotid stenosis( \>70%, by Doppler) related to the severe stroke
- neurological worsening (\>4 points in the NIHSS ) due to edema or intracerebral hemorrhage
- primary hematological disease
- neurodegenerative disorder
- previous stroke with mRS \> 2
- intracardiac thrombosis
- auto-imune disorders
- osteopathies that could increase the risk of bone marrow harvesting procedure
- thrombophilias
- liver failure
- chronic renal failure (creatinine \> 2mg/ml)
- life support dependence
- lacunar stroke
- pregnancy
- history of neoplasia or other comorbidity that could impact patient's short-term survival
- any condition that in the judgment of the investigator would place the patient under undue risk
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00473057
Start Date
December 1 2005
End Date
May 1 2011
Last Update
May 19 2011
Active Locations (1)
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1
Hospital Universitário Clementino Fraga Filho/UFRJ
Rio de Janeiro, Rio de Janeiro, Brazil, 21.941-590