Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

U

Universidade Federal do Rio de Janeiro

Status and phase

Completed
Phase 1

Conditions

Infarction, Middle Cerebral Artery

Treatments

Other: Autologous cell transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00473057
Proc.-CNPq-55.2201/2005-7
CONEP-10385
CEP-HUCFF/UFRJ-169/03

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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