Randomized Clinical Trial in Parkinson's Disease Patients Using Pluripotent Adipose Stem Cells (PASCs)

Prior treatment

• Drug-induced Parkinsonism
• Use of cytostatic drugs
• Use of systemic steroids or immunosuppressive drugs

Other illness

• Parkinsonism associated with stroke, progressive supranuclear palsy, Lewy body disease, corticobasal degeneration, or multiple system atrophy
• Major psychiatric comorbidity that prevents ensuring study follow-up
• History of alcohol or drug use
• History of brain surgery for Parkinson's Disease
• Active infectious disease requiring medical treatment
• Patients positive for Hepatitis B antigen, Hepatitis C antibody, or HIV antibody
• History of active mesenchymopathies
• Active malignancy or diagnosis of malignancy in the last 5 years

Lab values

• Diagnosis of advanced-stage medical conditions (chronic liver injury with Child-Pugh B or higher, chronic obstructive pulmonary disease with Gold C or higher, or heart failure with ejection fraction \<35%)
• Diabetes mellitus with poor metabolic control (HbA1c \> 8%)
• Abnormal laboratory values, including:
  • AST \>1.5 times Upper Limit of Normal (ULN) (Normal Range: 8 to 48 Units/L)
  • ALT \>1.5 times ULN (Normal Range: 7 to 55 Units/L)
  • Bilirubin \>1.5 times ULN (Normal Range: 0.2 to 1.2 mg/dL)
  • Creatinine \>1.5 times ULN (Normal Range: 0.5 to 1.30 mg/dL)
  • Hematocrit significantly outside normal range (36% to 54%)
  • Lymphocytes significantly outside normal range (103 to 4.8 x 103 lymphocytes/μL)
  • Monocytes significantly outside normal range (200 to 800 lymphocytes/μL)
  • Neutrophils significantly outside normal range (2.5 x 103 to 7 x 103 lymphocytes/μL)
  • Erythrocytes significantly outside normal range (4.7 x 106 to 6.1 x 106 lymphocytes/μL)
  • Platelets significantly outside normal range (150 x 103 to 450 x 103 lymphocytes/μL)

Other

• Serious complications deemed inappropriate by Principal Investigator
• Patients with life expectancy \< 6 months
• Fertile, pregnant, possibly pregnant, or lactating women

• Men ≥18 years of age or women ≥45 years of age
• Written informed consent
• Receiving drug treatment for diagnosis of mild to moderate Parkinson's Disease
• Modified Hoehn and Yahr stage 1, 2, or 3
• Diagnosed with Parkinson's Disease for more than 5 years
• Stable treatment regimen that has not been modified in the 90 days prior to the start of the study
• No expected addition of symptomatic therapy for at least one year after the start of the study
• Women of reproductive age must use contraceptive treatment