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

Tracking Information
First Received Date ^ICMJE	September 28, 2008
Last Updated Date	November 27, 2011
Start Date ^ICMJE	September 2008
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 28, 2008)	Absence of new neurological deficits and adverse effects during the timeframe. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00761982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 28, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
Official Title ^ICMJE	Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Stroke, Acute Infarction, Middle Cerebral Artery
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Piñero P, Espigado I, Garcia-Solis D, Cayuela A, Montaner J, Boada C, Rosell A, Jimenez MD, Mayol A, Gil-Peralta A. Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke. 2012 Aug;43(8):2242-4. Epub 2012 Jul 3. Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	20
Completion Date	August 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT00761982
Other Study ID Numbers ^ICMJE	OVISEV-01
Has Data Monitoring Committee	No
Responsible Party	Hospital Universitario Central de Asturias
Study Sponsor ^ICMJE	Hospital Universitario Central de Asturias
Collaborators ^ICMJE	Hospitales Universitarios Virgen del Rocío
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital Universitario Central de Asturias
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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