Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

May 18, 2011 updated by: Universidade Federal do Rio de Janeiro

Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21.941-590
        • Hospital Universitário Clementino Fraga Filho/UFRJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of neurological deficits
Time Frame: 4 months
4 months
Improvement in the neuroimaging exams
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Ministry of Health, Brazil
National Research Council, Brazil
Ministry of Science and Technology, 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 10, 2007

First Submitted That Met QC Criteria

May 10, 2007

First Posted (Estimate)

May 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONEP-10385
  • CEP-HUCFF/UFRJ-169/03
  • Proc.-CNPq-55.2201/2005-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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