Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson

Conditions: Idiopathic Parkinson Disease, Parkinson's Disease and Parkinsonism

Summary

This is an interventional study to treat 10 patients with a diagnosis of Parkinson's disease with neurological assessment from the Oxford Parkinson's Disease Quotient-39 (PDQ-39) and Movement Disorders Society Universal Parkinson's Disease Rating Scale (MDS-UPDRS), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells by subdermal plane injection into the submuscular aponeurotic fascia of the face.This study assesses: 1) safety and 2) feasibility and 3) exploratory evidence of efficacy.

Eligibility Criteria

Inclusion Criteria:Subjects with UK brain bank criteria for idiopathic Parkinson's disease for a period of not less than one yearAge 18 - 80; male or femaleStable PD medication for at least 30 days prior to study enrollmentA MDS-UPDRS total score > 20 and < 50Ability to understand the study and sign consent formsIntent to comply with all postoperative appointmentsSocial support to be able to comply with all follow-up visitsExclusion Criteria:Previous neurological disease or previous brain trauma as a confounding factorCardiovascular disease or any condition that prohibits general anesthesiaInability to understand and / or cooperate with investigatorsSubjects 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

Source: ClinicalTrials.gov (NCT05699161). StuddyBuddy aggregates publicly available trial information.