Status:
UNKNOWN
Randomized Clinical Trial in Parkinson's Disease Patients Using Pluripotent Adipose Stem Cells (PASCs)
Lead Sponsor:
ClusterXStem-Costa Rica
Collaborating Sponsors:
Universidad de Costa Rica
University of California, Los Angeles
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Drug-induced Parkinsonism
- 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
- Serious complications deemed inappropriate by Principal Investigator
- 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%)
- Use of cytostatic drugs
- Patients with life expectancy \< 6 months
- Diabetes mellitus with poor metabolic control (HbA1c \> 8%)
- Active infectious disease requiring medical treatment
- Use of systemic steroids or immunosuppressive drugs
- Patients positive for Hepatitis B antigen, Hepatitis C antibody, or HIV antibody
- Fertile, pregnant, possibly pregnant, or lactating women
- History of active mesenchymopathies
- Active malignancy or diagnosis of malignancy in the last 5 years
- 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)
Key Trial Info
Start Date :
June 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06141317
Start Date
June 23 2023
End Date
November 1 2024
Last Update
December 1 2023
Active Locations (2)
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1
Hospital Clínica Católica
San José, Costa Rica, 10801
2
Clínica NeuroFT
San José, Costa Rica