Randomized Clinical Trial in Parkinson's Disease Patients Using Pluripotent Adipose Stem Cells (PASCs)
NCT ID: NCT06141317
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2023-06-23
2024-11-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PASC transplantation (25 million PASCs/patient)
Pluripotent Adipose-Derived Stem Cells will be delivered intravenously
PASC transplantation (25 million PASCs/patient)
3 doses of 25 million PASCs implantation via peripheral vein (Day 0, 3 months, 6 months)
Control
Saline solution will be delivered intravenously
Control
0.9% saline solution via peripheral vein (Day 0, 3 months, 6 months)
Interventions
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PASC transplantation (25 million PASCs/patient)
3 doses of 25 million PASCs implantation via peripheral vein (Day 0, 3 months, 6 months)
Control
0.9% saline solution via peripheral vein (Day 0, 3 months, 6 months)
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
80 Years
ALL
No
Sponsors
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Universidad de Costa Rica
OTHER
University of California, Los Angeles
OTHER
ClusterXStem-Costa Rica
OTHER
Responsible Party
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Principal Investigators
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Freddy Henriquez, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínica Católica
Locations
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Hospital Clínica Católica
San José, , Costa Rica
Clínica NeuroFT
San José, , Costa Rica
Countries
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References
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Heneidi S, Simerman AA, Keller E, Singh P, Li X, Dumesic DA, Chazenbalk G. Awakened by cellular stress: isolation and characterization of a novel population of pluripotent stem cells derived from human adipose tissue. PLoS One. 2013 Jun 5;8(6):e64752. doi: 10.1371/journal.pone.0064752. Print 2013.
Gimeno ML, Fuertes F, Barcala Tabarrozzi AE, Attorressi AI, Cucchiani R, Corrales L, Oliveira TC, Sogayar MC, Labriola L, Dewey RA, Perone MJ. Pluripotent Nontumorigenic Adipose Tissue-Derived Muse Cells have Immunomodulatory Capacity Mediated by Transforming Growth Factor-beta1. Stem Cells Transl Med. 2017 Jan;6(1):161-173. doi: 10.5966/sctm.2016-0014. Epub 2016 Aug 2.
Simerman AA, Phan JD, Dumesic DA, Chazenbalk GD. Muse Cells: Nontumorigenic Pluripotent Stem Cells Present in Adult Tissues-A Paradigm Shift in Tissue Regeneration and Evolution. Stem Cells Int. 2016;2016:1463258. doi: 10.1155/2016/1463258. Epub 2016 Dec 14.
Fisch SC, Gimeno ML, Phan JD, Simerman AA, Dumesic DA, Perone MJ, Chazenbalk GD. Pluripotent nontumorigenic multilineage differentiating stress enduring cells (Muse cells): a seven-year retrospective. Stem Cell Res Ther. 2017 Oct 18;8(1):227. doi: 10.1186/s13287-017-0674-3.
Yamashita T, Kushida Y, Abe K, Dezawa M. Non-Tumorigenic Pluripotent Reparative Muse Cells Provide a New Therapeutic Approach for Neurologic Diseases. Cells. 2021 Apr 20;10(4):961. doi: 10.3390/cells10040961.
Leung KL, Chazenbalk GD. Human Pluripotent Nontumorigenic Multilineage Differentiating Stress Enduring (Muse) Cells Isolated from Adipose Tissue: A New Paradigm in Regenerative Medicine and Cell Therapy. In Scientific Principles of Adipose Stem Cells, edited by: L Kokai, K Marra, JP Rubin, Editorial Elsevier, Chapter 6, 91-108, 1st Edition, 2021, https://doi.org/10.1016/B978-0-12-819376-1.00004-4
Related Links
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Patent: Pluripotent human adipose adult stem cells: isolation, characterization and clinical implications
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id