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 Parkinson's Disease 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 Vertebral Artery and intravenously.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The adipose tissue specimen will be collected from the patient's abdomen or applicable region using a liposuction cannula. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for catheter injection.
Ageless Regenerative Institute LLC
Aventura, Florida, United States
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior
Improvement in Mentation, Behavior and mood in on and off position
Time frame: 3 months
Number of participants with adverse events
Time frame: 1 week
UPDRS- Improvement in Activities of Daily Living
Time frame: 3 months
UPDRS- Improvement in motor Examination
Values compared to baseline
Time frame: 3 months
UPDRS- MODIFIED HOEHN AND YAHR STAGING
Compared to baseline
Time frame: 3 months
UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
Time frame: 3 months
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)Behavior
Improvement in Mentation, Behavior and mood in on and off position
Time frame: 6 months
Number of participants with adverse events
Time frame: 2 weeks
Number of participants with adverse events
Time frame: 4 weeks
UPDRS- Improvement in Activities of Daily Living
Time frame: 6 months
UPDRS- Improvement in motor Examination
Time frame: 6 months
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UPDRS- MODIFIED HOEHN AND YAHR STAGING
Time frame: 6 months
UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
Time frame: 6 months
Reduction of Parkinson's medications
Time frame: 3 months
Improvement in subjective symptoms: facial expression, gait, and freezing
Time frame: 3 months
Reduction of Parkinson's medications
Time frame: 6 months
Improvement in subjective symptoms: facial expression, gait, and freezing
Time frame: 6 months