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

Primary Purpose

Stroke, Acute, Infarction, Middle Cerebral Artery

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Infusion on autologous CD34+ stem cells into middle cerebral artery
Sponsored by
Hospital Universitario Central de Asturias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospitales Universitarios Virgen del Rocío
  • Hospital Universitario Central de Asturias

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

bone marrow stem cells

Arm Description

Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery.

Outcomes

Primary Outcome Measures

Absence of new neurological deficits and adverse effects during the timeframe.

Secondary Outcome Measures

Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale.

Full Information

First Posted
September 28, 2008
Last Updated
November 27, 2011
Sponsor
Hospital Universitario Central de Asturias
Collaborators
Hospitales Universitarios Virgen del Rocío
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1. Study Identification

Unique Protocol Identification Number
NCT00761982
Brief Title
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
Official Title
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario Central de Asturias
Collaborators
Hospitales Universitarios Virgen del Rocío

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Infarction, Middle Cerebral Artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bone marrow stem cells
Arm Type
Other
Arm Description
Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery.
Intervention Type
Procedure
Intervention Name(s)
Infusion on autologous CD34+ stem cells into middle cerebral artery
Intervention Description
Intraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients
Primary Outcome Measure Information:
Title
Absence of new neurological deficits and adverse effects during the timeframe.
Time Frame
Duration of study
Secondary Outcome Measure Information:
Title
Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale.
Time Frame
Duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospitales Universitarios Virgen del Rocío
City
Sevilla
State/Province
Andalucia
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22764211
Citation
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.
Results Reference
derived
PubMed Identifier
22163120
Citation
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.
Results Reference
derived

Learn more about this trial

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

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