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Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

Primary Purpose

Infarction, Middle Cerebral Artery

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Autologous cell transplantation

About this trial

This is an interventional treatment trial for Infarction, Middle Cerebral Artery focused on measuring acute stroke, middle cerebral artery, autologous transplantation, bone marrow cells, stem cells, cell therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Universitário Clementino Fraga Filho/UFRJ

Outcomes

Primary Outcome Measures

Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.

Secondary Outcome Measures

Improvement of neurological deficits

Improvement in the neuroimaging exams

Full Information

NCT ID

NCT00473057

First Posted

May 10, 2007

Last Updated

May 18, 2011

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00473057

Brief Title

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

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infarction, Middle Cerebral Artery

Keywords

acute stroke, middle cerebral artery, autologous transplantation, bone marrow cells, stem cells, cell therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Autologous cell transplantation

Intervention Description

Intra-arterial or intravenous delivery of autologous bone marrow cells

Primary Outcome Measure Information:

Title

Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Improvement of neurological deficits

Time Frame

4 months

Title

Improvement in the neuroimaging exams

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles André, MD, PhD

Organizational Affiliation

Universidade Federal do Rio de Janeiro

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gabriel R de Freitas, MD, PhD

Organizational Affiliation

Universidade Federal do Rio de Janeiro

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rosalia Mendez-Otero, Md, PhD

Organizational Affiliation

Universidade Federal do Rio de Janeiro

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lea Mirian Barbosa da Fonseca, MD, PhD

Organizational Affiliation

Universidade Federal do Rio de Janeiro

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitário Clementino Fraga Filho/UFRJ

City

Rio de Janeiro

State/Province

ZIP/Postal Code

21.941-590

Country

Brazil

12. IPD Sharing Statement

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Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

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