Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

NCT ID: NCT00473057

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2011-05-31

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.

Conditions

Infarction, Middle Cerebral Artery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Autologous cell transplantation

Intra-arterial or intravenous delivery of autologous bone marrow cells

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology, Brazil

OTHER

Sponsor Role: collaborator

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

National Research Council, Brazil

OTHER

Sponsor Role: collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Universidade Federal do Rio de Janeiro

Principal Investigators

Charles André, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Gabriel R de Freitas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Rosalia Mendez-Otero, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Lea Mirian Barbosa da Fonseca, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

Hospital Universitário Clementino Fraga Filho/UFRJ

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

CEP-HUCFF/UFRJ-169/03

Identifier Type: -

Identifier Source: secondary_id

Proc.-CNPq-55.2201/2005-7

Identifier Type: -

Identifier Source: secondary_id

CONEP-10385

Identifier Type: -

Identifier Source: org_study_id