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

Tissue Regeneration and Function Recovery in Patients With Parkinson's Disease Using Allogenic Pluripotent Stem Cells Isolated From Adipose Tissue (PASCs): A Randomized Phase I/IIa Clinical Trial (REPOSE)

The purpose of this study is to assess the safety and efficacy of allogenic pluripotent stem cells isolated from adipose tissue (PASCs) in patients with Parkinson's Disease.

Pluripotent Adipose-Derived Stem Cells (PASCs) will be delivered intravenously at a dosage of 25 million PASCs/patient to Parkinson's Disease patients for three infusions each spaced 3 months apart (0, 3, and 6 months). Safety and efficacy of PASC treatment will be monitored over 0, 1, 3, 6, and 12 months.

Inclusion Criteria:

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

Exclusion Criteria:

1. Drug-induced Parkinsonism

2. Parkinsonism associated with stroke, progressive supranuclear palsy, Lewy body disease, corticobasal degeneration, or multiple system atrophy

3. Major psychiatric comorbidity that prevents ensuring study follow-up

4. History of alcohol or drug use

5. History of brain surgery for Parkinson's Disease

6. Serious complications deemed inappropriate by Principal Investigator

7. 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%)

8. Use of cytostatic drugs

9. Patients with life expectancy < 6 months

10. Diabetes mellitus with poor metabolic control (HbA1c > 8%)

11. Active infectious disease requiring medical treatment

12. Use of systemic steroids or immunosuppressive drugs

13. Patients positive for Hepatitis B antigen, Hepatitis C antibody, or HIV antibody

14. Fertile, pregnant, possibly pregnant, or lactating women

15. History of active mesenchymopathies

16. Active malignancy or diagnosis of malignancy in the last 5 years

17. 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)