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

September 28, 2008
November 27, 2011
September 2008
August 2011   (final data collection date for primary outcome measure)
Absence of new neurological deficits and adverse effects during the timeframe. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00761982 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke, Acute
  • Infarction, 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
bone marrow stem cells
Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery.
Intervention: Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00761982
OVISEV-01
No
Hospital Universitario Central de Asturias
Hospital Universitario Central de Asturias
Hospitales Universitarios Virgen del Rocío
Not Provided
Hospital Universitario Central de Asturias
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP