Infarction, Middle Cerebral Artery
Conditions
Keywords
acute stroke, middle cerebral artery, autologous transplantation, bone marrow cells, stem cells, cell therapy
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-acute phase (\> 3 and \< 90 days after symptoms onset) of ischemic cerebral infarct in the middle cerebral artery territory. Methods: 15 patients with cerebral infarct within the middle cerebral artery territory will be enrolled in this prospective, nonrandomized, open-labeled study. Up to 10 patients will receive up to 500x 10 6 autologous bone marrow cells injected intra-arterially into the middle cerebral artery through percutaneous approach. The procedure is monitored by Transcranial Doppler (TCD) and electroencephalogram (EEG). Other 5 patients will receive up to 500x 10 6 autologous bone marrow cells injected intravenously. Changes in neurological deficits and improvements in functions will be evaluated at baseline and at regular intervals during follow-up ( 4 months). EEG and neuroimaging exams will be performed at baseline and at regular intervals during the follow-up period.
Interventions
Intra-arterial or intravenous delivery of autologous bone marrow cells
Sponsors
Ministry of Science and Technology, Brazil
Ministry of Health, Brazil
National Research Council, Brazil
Universidade Federal do Rio de Janeiro
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of new neurological deficits during the procedure and/or in the 4 months follow-up. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of neurological deficits | 4 months |
| Improvement in the neuroimaging exams | 4 months |
Countries
Brazil
Outcome results
None listed