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Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT00473057
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : May 19, 2011
Sponsor:
Collaborators:
Ministry of Science and Technology, Brazil
Ministry of Health, Brazil
National Research Council, Brazil
Information provided by:
Universidade Federal do Rio de Janeiro

Tracking Information
First Submitted Date  ICMJE May 10, 2007
First Posted Date  ICMJE May 14, 2007
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE December 2005
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
Absence of new neurological deficits during the procedure and/or in the 4 months follow-up. [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2007)
  • Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.
  • No abnormalities in neuroimaging exams
  • Absence of epileptiform activity during the procedure ans /or in the 4 months follow-up.
Change History Complete list of historical versions of study NCT00473057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
  • Improvement of neurological deficits [ Time Frame: 4 months ]
  • Improvement in the neuroimaging exams [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2007)
  • Improvement of neurological deficits
  • Improvement in the neuroimaging exams
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke
Official Title  ICMJE Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infarction, Middle Cerebral Artery
Intervention  ICMJE Other: Autologous cell transplantation
Intra-arterial or intravenous delivery of autologous bone marrow cells
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2011)
12
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2007)
10
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00473057
Other Study ID Numbers  ICMJE CONEP-10385
CEP-HUCFF/UFRJ-169/03
Proc.-CNPq-55.2201/2005-7
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles Andre, MD, PhD, Universidade Federal do Rio de Janeiro
Study Sponsor  ICMJE Universidade Federal do Rio de Janeiro
Collaborators  ICMJE
  • Ministry of Science and Technology, Brazil
  • Ministry of Health, Brazil
  • National Research Council, Brazil
Investigators  ICMJE
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
PRS Account Universidade Federal do Rio de Janeiro
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP