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The intent of this clinical study is to answer the questions:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Injection and Intanasal infusion of AD-SVF | Experimental | AD-SVF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvesting and Implantation of Adipose-Derived Stem Cells | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior | Improvement in Mentation, Behavior and mood in on and off position | 3 months |
| Number of participants with adverse events | 1 week | |
| UPDRS- Improvement in Activities of Daily Living | 3 months | |
| UPDRS- Improvement in motor Examination | Values compared to baseline | 3 months |
| UPDRS- MODIFIED HOEHN AND YAHR STAGING | Compared to baseline | 3 months |
| UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE | 3 months | |
| UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)Behavior | Improvement in Mentation, Behavior and mood in on and off position | 6 months |
| Number of participants with adverse events | 2 weeks | |
| Number of participants with adverse events | 4 weeks | |
| UPDRS- Improvement in Activities of Daily Living |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Parkinson's medications | 3 months | |
| Improvement in subjective symptoms: facial expression, gait, and freezing | 3 months | |
| Reduction of Parkinson's medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon McQuillan, MD | Ageless Regenerative Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ageless Regenerative Institute LLC | Aventura | Florida | 33180 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 6 months |
| UPDRS- Improvement in motor Examination | 6 months |
| UPDRS- MODIFIED HOEHN AND YAHR STAGING | 6 months |
| UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE | 6 months |
| 6 months |
| Improvement in subjective symptoms: facial expression, gait, and freezing | 6 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |