The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients after Stroke and clinical outcomes?
Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from stroke. By injecting ASCs either into the internal carotid artery, these regions may become populated with the ASCs, thereby potentially restoring brain function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient into the internal carotid artery and intravenously. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
This will be an open-label, non-randomized multi-center patient sponsored study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be implanted into the Internal Carotid Artery and intravenously.
Hospital Angeles
Tijuana, Estado de Baja California, Mexico
Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months
Time frame: 3 months
Number of participants with adverse events
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Time frame: 1 week
Number of participants with adverse events at 2 weeks
Time frame: two weeks
Number of participants with adverse events at 4 weeks
Time frame: 4 weeks
Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months
Time frame: 6 months
Number of participants with adverse events at 3 weeks
Time frame: 3 weeks
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months
Time frame: 6 months
Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months
Time frame: 3 months
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months
Time frame: 3 months
Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months
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Time frame: 3 months
Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months
Time frame: 6 months
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months
Time frame: 6 months
Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months
Time frame: 6 months