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Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.

This study has been completed.
Sponsor:
Collaborator:
Hospitales Universitarios Virgen del Rocío
Information provided by (Responsible Party):
Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier:
NCT00761982
First received: September 28, 2008
Last updated: November 27, 2011
Last verified: November 2011
History of Changes
  Purpose

The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.


Condition Intervention Phase
Stroke, Acute
Infarction, Middle Cerebral Artery
 Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitario Central de Asturias:

Primary Outcome Measures:
  • Absence of new neurological deficits and adverse effects during the timeframe. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
bone marrow stem cells
Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery.
 Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery
Intraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients

Detailed Description:

The proposed trial will involve the recruitment of a total of 20 patients.

The cells will be collected from ten subject recruited as cases, via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, which will be resuspended in heparinized isotonic saline for infusion into the area of the stroke intra-arterially using the middle cerebral artery.

The investigators will monitor each case and control for a period of 6 months post-stem cell infusion. Initially, they will be subjected to a review after one month,three months and finally 6 months.

Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms and signs of clinically definite middle cerebral artery acute stroke.
  • Time of stroke onset is known and treatment can be started between day 5 and 9 of onset.
  • DWI-MRI has reliably shown relevant acute ischemic lesions
  • Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability.
  • The stroke is severe (NIH Stroke Scale >= 8 before procedure).
  • An age range of 18-80 years old.

Exclusion Criteria:

  • Patients out of inclusion age range.
  • Lacunar infarction.
  • Patients with cancer.
  • Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma.
  • Hematological causes of stroke.
  • Severe co-morbidity.
  • Hepatic or renal dysfunction.
  • The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding.
  • Patient is likely to be unavailable for follow-up.
  • Patient with evidence of life threatening infection of life threatening illness.
  • Patient was already dependent in activities of daily living before the present acute stroke.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761982

Locations
Spain
Hospitales Universitarios Virgen del Rocío
Sevilla, Andalucia, Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Sponsors and Collaborators
Hospital Universitario Central de Asturias
Hospitales Universitarios Virgen del Rocío
  More Information

No publications provided by Hospital Universitario Central de Asturias

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier: NCT00761982     History of Changes
Other Study ID Numbers: OVISEV-01
Study First Received: September 28, 2008
Last Updated: November 27, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Infarction
Stroke
Cerebral Infarction
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on May 23, 2013