Safety of adipose-derived stromal vascular fraction cells to treat Parkinson's disease.

Abstract

Neuroinflammation is a significant correlate of Parkinson's Disease (PD), with positron emission tomography showing microglial activation early in the PD process and post-mortem tissue containing reactive microglia. Adipose-derived (AD) stromal vascular fraction (SVF) cells have been shown to respond to pro-inflammatory conditions with secretion of anti-inflammatory paracrine factors. This pilot clinical trial was to examine the safety and clinical response using autologous ADSVF to treat PD. Nine PD subjects had baseline neurological exams and Parkinson's Disease Questionnaire 39 (PDQ-39) and "off-medication" Movement Disorder Society (MDS) - Unified Parkinson's Disease Rating Scale (UPDRS) Part III assessments. Each subject had a liposuction procedure; the lipoaspirate was then processed via enzymatic digestion to yield SVF. All subjects were treated with a total dose of 30 million autologous SVF cells injected in the forehead and maxillary regions. Subjects were followed at 1-, 3-, 6-, 12-, and 24-months for safety and potential clinical improvement. There were no SVF intervention-related serious adverse events. PDQ-39 scores at 12-months and 24-months were improved in 6 of 9 subjects evaluable and 4 of 7 subjects evaluable, respectfully. Scores were stable in 1 subject and worse in 2 subjects. MDS-UPDRS Part III scores were improved at 24, months in 3 evaluable subjects and were stable in 2 subjects. One subject required increased dopaminergic medication for increased tremor (disease progression). Autologous ADSVF via facial injections to treat PD was safe, showed evidence of clinical improvement at 12 and 24 months and should be further evaluated in a Phase II placebo-controlled clinical trial.