Clinical trial NCT00761982: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke, Acute
Infarction, Middle Cerebral Artery
Lead sponsor: Hospital Universitario Central de Asturias
Sponsor class: OTHER
Collaborators: name: Hospitales Universitarios Virgen del Rocío
First posted: 2008-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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.

Primary outcomes:
measure: Absence of new neurological deficits and adverse effects during the timeframe.
timeFrame: Duration of study
Secondary outcomes:
measure: Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale.
timeFrame: Duration of study
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospitales Universitarios Virgen del Rocío
state: Andalucia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
Study officials:
References:
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.
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.