Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

This study has been completed.
Sponsor:
Collaborators:
Brazil, Ministery of Science and Technology
Ministry of Health, Brazil
National Research Council, Brazil
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00473057
First received: May 10, 2007
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Infarction, Middle Cerebral Artery
Other: Autologous cell transplantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Absence of new neurological deficits during the procedure and/or in the 4 months follow-up. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of neurological deficits [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Improvement in the neuroimaging exams [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: December 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Autologous cell transplantation
    Intra-arterial or intravenous delivery of autologous bone marrow cells
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473057

Locations
Brazil
Hospital Universitário Clementino Fraga Filho/UFRJ
Rio de Janeiro, RJ, Brazil, 21.941-590
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Brazil, Ministery of Science and Technology
Ministry of Health, Brazil
National Research Council, Brazil
Investigators
Principal Investigator: Charles André, MD, PhD Universidade Federal do Rio de Janeiro
Principal Investigator: Gabriel R de Freitas, MD, PhD Universidade Federal do Rio de Janeiro
Principal Investigator: Rosalia Mendez-Otero, Md, PhD Universidade Federal do Rio de Janeiro
Principal Investigator: Lea Mirian Barbosa da Fonseca, MD, PhD Universidade Federal do Rio de Janeiro
  More Information

No publications provided

Responsible Party: Charles Andre, MD, PhD, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00473057     History of Changes
Other Study ID Numbers: CONEP-10385, CEP-HUCFF/UFRJ-169/03, Proc.-CNPq-55.2201/2005-7
Study First Received: May 10, 2007
Last Updated: May 18, 2011
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health

Keywords provided by Universidade Federal do Rio de Janeiro:
acute stroke
middle cerebral artery
autologous transplantation
bone marrow cells
stem cells
cell therapy

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Infarction
Stroke
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Infarction
Brain Infarction
Brain Ischemia
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on July 24, 2014