Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson (SVFP1)
Idiopathic Parkinson Disease, Parkinson's Disease and Parkinsonism
About this trial
This is an interventional treatment trial for Idiopathic Parkinson Disease
Eligibility Criteria
Inclusion Criteria: Subjects with UK brain bank criteria for idiopathic Parkinson's disease for a period of not less than one year Age 18 - 80; male or female Stable PD medication for at least 30 days prior to study enrollment A MDS-UPDRS total score > 20 and < 50 Ability to understand the study and sign consent forms Intent to comply with all postoperative appointments Social support to be able to comply with all follow-up visits Exclusion Criteria: Previous neurological disease or previous brain trauma as a confounding factor Cardiovascular disease or any condition that prohibits general anesthesia Inability to understand and / or cooperate with investigators Subjects that have a history of injury, infection, or deformity of at or near the anatomical site for planned product injection which may increase their risk for infection, injury, or complication related to the product (e.g., prior injury to blood vessels, lymphatics, history of orbital injury/fracture). Rash or possible skin infection over surgical sites or face. Subjects that use any form of tobacco, including e-cigarettes, more than once a week over the past year. Current substance abuse (drugs or alcohol) within the 6 months prior to study enrollment
Sites / Locations
- Hospital Escuela Oscar Danilo Rosales Arguello
Arms of the Study
Arm 1
Experimental
Single group assignment.
Bilateral treatment. Subdermal plane injection of SVF cells into the submuscular aponeurotic fascia of the face.