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.

Study Overview

• Status: Completed
• Conditions: Infarction, Middle Cerebral Artery; Stroke, Acute
• Intervention / Treatment: Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Sevilla, Andalucia, Spain
      • Hospitales Universitarios Virgen del Rocío
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Hospital Universitario Central de Asturias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absence of new neurological deficits and adverse effects during the timeframe.	Duration of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale.	Duration of study

Collaborators and Investigators

• Sponsor: Hospital Universitario Central de Asturias
• Collaborators: Hospitales Universitarios Virgen del Rocío

Publications and helpful links

General Publications

• Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Pinero 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. doi: 10.1161/STROKEAHA.112.659409. 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: September 28, 2008
• First Submitted That Met QC Criteria: September 28, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): November 29, 2011
• Last Update Submitted That Met QC Criteria: November 27, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Brain Infarction; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebral Infarction; Infarction; Stroke; Infarction, Middle Cerebral Artery
• Other Study ID Numbers: OVISEV-01