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Parkinson DiseasePhase 1/2NCT06141317

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

A Phase 1/2 study testing PASC transplantation (25 million PASCs/patient) in people with Parkinson Disease, run by ClusterXStem-Costa Rica at 2 sites in Costa Rica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
PASC transplantation (25 million PASCs/patient)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesCosta Rica
Study dates
23 Jun 2023to 1 Sep 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

Costa Rica2 sites

  • Clínica NeuroFT

    San José, Provincia de San José

  • Hospital Clínica Católica

    San José, 10801

Other trials in Costa Rica

About this study

Official title: 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.

Read the 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, 3, and 6 months). Safety and efficacy of PASC treatment will be monitored over 0, 1, 3, 6, and 12 months.

Being tested
PASC transplantation (25 million PASCs/patient), Control
Keywords
Pluripotency, Non-tumorigenic, Neurodegenerative disease, Safety, Efficacy, Tissue/function regeneration, Improve symptoms, Potential cure
Medical subject headings
Parkinson Disease, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PASC transplantation (25 million PASCs/patient)Biological

    3 doses of 25 million PASCs implantation via peripheral vein (Day 0, 3 months, 6 months)

  • ControlBiological

    0.9% saline solution via peripheral vein (Day 0, 3 months, 6 months)

Study groups in NCT06141317
Study groupRoleWhat they receive
PASC transplantation (25 million PASCs/patient)ExperimentalPluripotent Adipose-Derived Stem Cells will be delivered intravenously
Receives: Biological: PASC transplantation (25 million PASCs/patient)
ControlPlacebo comparatorSaline solution will be delivered intravenously
Receives: Biological: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in motor function as assessed by the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score

    The MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a widely used research tool to quantify the clinical characteristics of PD in adults. This scale assesses various aspects of Parkinson's disease, including motor and non-motor experiences of daily life and motor complications. This test will take approximately 30 minutes, assessing the impact of the disease in 4 different domains distributed in 65 items, of which 48 are scored from 0 to 4 and seven with dichotomous answers of "yes" or "no". The global range of the MDS-UPDRS will be from 0 to 260 points, the higher the score, the greater the disease involvement.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  2. Quality of life as assessed by the 39-item Parkinson's disease Questionnaire (PDQ-39)

    The 39-item Parkinson's disease Questionnaire (PDQ-39) is the most widely test used to assess specific quality of life questionnaire for Parkinson's disease, and it has been validated and cross-culturally translated. The questionnaire consists of 39 questions to be completed by the patient, that assesses the frequency in which patients with PD experience difficulties in 8 dimensions of functionality and well-being: mobility, activities of daily living, emotional well- being, attention and memory, social support, depression, cognition, communication and social relationships. Items can be transformed on a linear scale from 0 to 100, the higher the score reflects a lower quality of life.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  3. Speech voice sound and duration

    Since most people with Parkinson's disease (PD) have voice and speech disorders that result in harmful effects on communication and quality of life; the measurement of the pressure level and sound duration will be executed using the Samson Go Mic and the software used for the Lee Silverman Voice Treatment Therapy (LSVT LOUD).

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  4. Dynamic balance and movement during translational motion and single-limb stance in seconds as assessed by the Mini Balance Evaluation Systems Test (mini BESTest)

    The Mini Balance Evaluation Systems Test (mini BESTest) has proven to be a reliable and valid measurement tool for patients with PD. It is aimed to measure dynamic balance and associated movement during translational motion. The test consists of 14 items, with a maximum score of 28 points, with a higher test result, the greater the patient's functionality 35 . The test has high inter-rater reliability (ICC = 0.92) and high test-retest reliability (ICC = 0.92) for PD patients.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  5. Balance as assessed by the The Five-times Sit-to-stand Test

    The Five-times sit-to-stand Test is a tool that quantifies the ability of patients suffering from diseases associated with balance problems, as in the case of PD, to perform transitional motions. In addition, it has been used as a measure of lower limb strength. The test has excellent inter-rater reliability and high test-retest reliability, as well as assessing for the risk of falls in patients with PD.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  6. Mobility and fall risk as assessed by the Timed "Up & Go" test

    The Timed "Up \& Go" test consists of observing and timing the patient as he gets up from an armchair, walking for 3 meters, turns, returns and sits down again. The results of this test correlates well with the logarithmic transformation scores on the Berg Balance Scale, gait speed and the Barthel Index of AVD (Activities of Daily Living), and can predict the patient's ability to walk alone safely.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  7. Balance and postural stability as assessed by the Clinical test of Sensory Interaction & Balance Test (CTSIB), stability limits, and unipodal balance test

    Computerized posturography using a force platform system provides objective and quantitative evaluations of deficiencies in postural control. The participants of the present study will be subjected to two tests of balance and postural stability using the HUMAC®43 brand force platform system. Three tests will be performed: CTSIB test (Clinical test of Sensory Interaction \& Balance), the stability limits, and the unipodal balance test.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  8. Tremor and handwriting

    Alterations in the kinematics of handwriting are among the recently proposed biomarkers of PD. Recent studies have suggested the potential of handwriting analysis for both early diagnosis and assessment of disease progression. In the present study, the patients will be subjected to 5 tests, at 5 different times of the study using the MovAlyzeR® software in conjunction with the WACOM ONE tablet, to measure the speed, amplitude, fluidity and tremor of the movements of the upper extremities.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  9. Grip strength

    The decrease in grip strength is a predictor of adverse outcomes in older adults and will be determined using a Jamar brand digital dynamometer to measure the grip strength of the patients participating in each assessment.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  10. Dynamic balance in the bipedal as measured by the 360 degree turn test

    This test measures dynamic balance in the bipedal. In this test, the number of steps and the time that take the patient to make a complete 360-degree turn will be measured.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

Secondary outcomes (2)

  1. Adverse events upon clinical examination

    Study participants will be examined for clinical signs of adverse events.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

  2. Optimal number of doses of 2.5 x 10^7 PASCs for therapeutic response

    The optimal number of doses of PASCs for therapeutic response will be measured.

    Measured: Day 0, 1 Month, 3 Months, 6 Months, 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2023
  2. Study start23 Jun 2023
  3. Primary completion23 Jun 2024
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06141317
Sponsor's protocol ID
1
Status last verified
Oct 2026
First submitted
15 Nov 2023
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23755141

  • 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.

    PubMed 28170177

  • 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.

    PubMed 28070194

  • 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.

    PubMed 29041955

  • 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.

    PubMed 33924240

  • 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

  • Gimeno ML, Chazenbalk G, Riggioni L, Ortega A, Miranda L, Valverde JA, Molina-Mora JA, Rojas LG, Vargas P, Zuniga C, Rosales L, Henriquez F. A pilot phase IIa randomized, placebo-controlled, double-blind trial of intravenous human pluripotent adipose-derived stem cells (PASCs) in Parkinson's disease: The REPOSE study. Cell Transplant. 2026 Jan-Dec;35:9636897261492438. doi: 10.1177/09636897261492438. Epub 2026 Sep 23.

    PubMed 42775498

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PASC transplantation (25 million PASCs/patient) in people with Parkinson Disease, run by ClusterXStem-Costa Rica at 2 sites in Costa Rica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in motor function as assessed by the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (time frame: Day 0, 1 Month, 3 Months, 6 Months, 12 Months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06141317, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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