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 with diffuse brain lesions and clinical outcomes.
This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (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 delivered via catheter into the internal carotid artery and intravenously.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Adipose-Derived Stem cells will be derived from the patient's fat 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 delivered via catheter into the internal carotid artery and intravenously.
Hospital Angeles
Tijuana, Estado de Baja California, Mexico
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline
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: up to 6 months
Improved cognitive function as measured by the mini mental state exam
Time frame: 3 months
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline
Time frame: 6 months
Improved cognitive function as measured by the mini mental state exam compared to baseline
Time frame: 6 months
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline
Time frame: 3 months
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline
Time frame: 6 months
number of brain lesions by MRI compared to baseline
Time frame: 3 months
Improved quality of life scores compared to baseline
Time frame: 3 months
Improved quality of life scores compared to baseline
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Time frame: 6 months
number of brain lesions by MRI compared to baseline
Time frame: 6 months