Ischemic Stroke
Conditions
Keywords
Stroke, Cell therapy, Bone marrow
Brief summary
This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.
Detailed description
This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent. 76 patients will randomize in proportion 2:1:1 in a group control that will receive only medical conventional treatment and in two groups of intervention that will receive an unique intra-arterial infusion of mononuclear autologous bone marrow stem cells (one group of dose of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC for kilogram of weight). The three groups of patients will be followed for 24 months. The randomization will be stratified depending on the NHSS score. This clinical trial has a voluntary substudy to obtain information on plasma biomarkers.
Interventions
DRUGAutologous bone marrow mononuclear cell intra-arterial injection
Sponsors
Andalusian Initiative for Advanced Therapies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with middle cerebral artery (MCA) acute ischemic stroke. * Time of stroke onset is known and treatment can be started between day 1 and 7 of onset. * DWI-MRI has reliably shown acute MCA ischemic lesions * Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability * National Institute of Health Stroke Scale score of 6-20 at inclusion * Age 18-80 years * Written informed consent has been obtained
Exclusion criteria
* Hemorrhagic stroke or symptomatic hemorrhagic transformation * Lacunar infarction * Preocclusive stenosis or total occlusion of ipsilateral carotid artery * Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema * Decrease of consciousness with a Glasgow Coma Scale of \<8 points * Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma * Contraindication for MRI or for bone marrow harvest * Previous diagnosis of neurodegenerative disease * Acute heart failure * Hepatic or renal dysfunction (creatinine \>2mg/dL) * Coagulopathy * Severe co-morbidity * Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding * Modified Rankin Score (mRS) before stroke of ≥2 * Participation in any clinical trial in the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 6 months | Proportion of patients with modified Rankin Scale scores of 0-2 at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Mortality | 24 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with new-onset seizures as a Measure of Safety and Tolerability | 6 months | — |
| Infarct volume | 6 months | Infarct volume change between baseline (DWI) and 6 months (FLAIR) |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 24 months | — |
| Functional outcomes | 6 months | Functional outcome measure by National Institute of Health Stroke Scale and Barthel at 6 months |
Countries
Spain
Outcome results
None listed