Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

Infarction, Middle Cerebral Artery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473057
• Other study ID #: CONEP-10385
• Secondary ID: CEP-HUCFF/UFRJ-1
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2007
• Last updated: May 18, 2011
• Start date: December 2005
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction, Middle Cerebral Artery

Intervention

Other:
• Autologous cell transplantation
Intra-arterial or intravenous delivery of autologous bone marrow cells

Locations

Country	Name	City	State
Brazil	Hospital Universitário Clementino Fraga Filho/UFRJ	Rio de Janeiro	RJ

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Ministry of Health, Brazil, Ministry of Science and Technology, Brazil, National Research Council, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.		4 months	Yes
Secondary	Improvement of neurological deficits		4 months	Yes
Secondary	Improvement in the neuroimaging exams		4 months	Yes