Clinical trial NCT00473057: Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke
Official title: Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infarction, Middle Cerebral Artery
Keywords: acute stroke
middle cerebral artery
autologous transplantation
bone marrow cells
stem cells
cell therapy
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Brazil
name: Ministry of Health, Brazil
name: National Research Council, Brazil
First posted: 2007-05-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.
timeFrame: 4 months
Secondary outcomes:
measure: Improvement of neurological deficits
timeFrame: 4 months
measure: Improvement in the neuroimaging exams
timeFrame: 4 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho/UFRJ
state: RJ
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Charles André, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Gabriel R de Freitas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Rosalia Mendez-Otero, Md, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Lea Mirian Barbosa da Fonseca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: