Clinical Research on Stem Cell Therapy for Parkinson's Disease

November 13, 2025 updated by: Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.

Clinical Study on the Safety, Tolerance and Preliminary Efficacy of Human Mesenchymal Stem Cell Therapy for Parkinson's Disease

This study, through different administration methods, adopted a randomized, double-blind, placebo-controlled trial design to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells (hUC-MSCs) in patients with Parkinson's disease, explore their initial effectiveness and the relationship between biological active factors and therapeutic efficacy. The "Clinical Study on the Treatment of Parkinson's Disease with Human Umbilical Cord Mesenchymal Stem Cells" of this study is expected to provide clinical trial evidence for the development of safe and effective clinical cell therapies for patients with Parkinson's disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Research Design and Implementation

(1) Inclusion, Exclusion and Withdrawal Criteria for Participants

  1. Case Inclusion Criteria:

    1.1 Male and female individuals aged between 40 and 70 years old, excluding adolescent patients with Parkinson's disease.

    1.2 According to the 2015 MDS Parkinson's disease diagnostic criteria, confirmed by a PI or other movement disorder experts based on medical history, physical examination and neurological examination.

    1.3 Modified Hoehn and Yahr staging under levodopa withdrawal period is less than or equal to 3 levels.

    1.4 Have applied levodopa-like drugs, and have a good response to dopaminergic treatment, that is, compared with the withdrawal period, the UPDRS score (combined Parkinson's disease rating scale) of the subjects during the on period decreased by more than 33%.

    1.5 If the subject is taking any central nervous system acting drugs (such as benzodiazepines, antidepressants, hypnotics), the treatment plan must be optimized and stabilized 90 days before the screening visit.

    1.6 At least 90 days before the screening, stable Parkinson's disease symptom treatment has been carried out, and no additional Parkinson's disease symptom treatment is needed from the baseline visit for at least one year.

    1.7 Pregnant women use reliable contraceptive methods during the period from 30 days before the baseline visit to 6 months after taking the study drug.

    1.8 Participants voluntarily join this study, sign the informed consent form, and fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.

  2. Case Exclusion Criteria:

    2.1 Atypical or drug-induced Parkinson's disease. 2.2 Any limb UPDRS resting tremor score of 3 or higher. 2.3 Montreal Cognitive Assessment (MoCA) score lower than 25 points. 2.4 Clinical features of psychosis or refractory hallucinations. 2.5 Epilepsy history, and having seizures within the past 6 months. 2.6 Mental retardation, possible or definite suicidal thoughts or behaviors, etc. mental disorders or symptoms.

    2.7 Chronic kidney disease: Glomerular filtration rate (GFR) < 50 ml/min/m2 as the diagnostic criterion.

    2.8 Liver function changes: Alanine transaminase (ALT) > 150 U/L and/or total bilirubin > 1.6 mg/dl.

    2.9 Clinical refractory orthostatic hypotension at the time of screening or at the baseline visit, with a systolic blood pressure change of greater than or equal to 20 mmHg and a diastolic blood pressure change of greater than or equal to 10 mmHg within 2 minutes from a sitting position to standing position, and ineffective with drug treatment or baseline sitting blood pressure less than 90/60 mmHg.

    2.10 Congestive heart failure history, clinically significant bradycardia, second or third degree atrioventricular block.

    2.11 Pulmonary disease: Chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.

    2.12 Active malignant tumors or diagnosed as malignant tumors within 5 years before the screening.

    2.13 Any autoimmune disease or immunodeficiency diagnosis, including recent 3-year chemotherapy or current use of immunosuppressive treatment, white blood cell (WBC) < 3 × 103 cells/ml.

    2.14 Moderate to severe cerebrovascular accident or traumatic brain injury history.

    2.15 Within the past 3 months or planned within the next 6 months to undergo major surgery.

    2.16 Clinically significant abnormalities in the laboratory study during the screening visit.

    2.17 History of using study medication within 30 days before the screening visit.

    2.18 History of brain surgery for Parkinson's disease. 2.19 Unable to return for clinical assessment, laboratory study or imaging assessment during the follow-up.

    2.20 History of drug abuse. 2.21 Active anticoagulation treatment or abnormal INR. 2.22 Other situations that researchers consider would cause significant danger to the subject or complicate the study assessment after enrollment.

  3. Withdrawal Criteria: 3.1 If the patient requests to withdraw or if the equivalent dose of levodopa changes by more than 30% compared to the baseline level, the subject is deemed unsuitable to continue the trial.
  4. Number of enrolled cases: It is planned to include 20 subjects who meet the inclusion and exclusion criteria.
  5. Administration route: Human umbilical cord mesenchymal stem cells were administered via intravenous infusion. Some subjects were also given the treatment through nasal instillation.
  6. Administration method: Human umbilical cord mesenchymal stem cells were administered intravenously once every 2 weeks, for a total of 5 times. Among them, half of the subjects (10 people) received nasal instillation of human umbilical cord mesenchymal stem cells once in the morning and once in the evening each day from the 6th to the 8th day after each administration; the remaining subjects (10 people) received nasal instillation of the stem cell solvent (0.9% sodium chloride injection containing 5% human albumin, which is consistent in appearance, packaging, instructions for use, and labels with the nasal administration preparation of human umbilical cord mesenchymal stem cells) once in the morning and once in the evening each day from the 6th to the 8th day after each administration. All subjects should receive basic treatment simultaneously during the trial period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The participants must meet all of the following criteria to be included in this study:

  1. The participants must fully understand and comply with the research procedures, voluntarily participate in the study and sign the informed consent form;
  2. At the time of signing the informed consent, the participants must be aged 18 or above and under 75 years old, with no gender restrictions;
  3. During the screening process, the participants must have had primary Parkinson's disease for at least 5 years, have a confirmed medical history record and meet the diagnostic criteria for primary Parkinson's disease as defined by the International Parkinson and Movement Disorder Society (MDS);
  4. During the screening, according to the MDS-UPDRS scoring scale, the Hoehn-Yahr classification of the "off" period of drug treatment is 2 to 4;
  5. During the screening, the score of the third part of the MDS-UPDRS in the "off" period must be greater than 30;
  6. During the screening, the stable duration of Parkinson's disease and the stable duration of the optimized drug dosage must be at least 4 weeks, and the duration of levodopa use must be at least 1 year;
  7. During the screening, the participants must have a response to levodopa treatment, and the levodopa loading test must be positive;
  8. The participants must experience a decline in the efficacy of anti-Parkinson's disease treatment, which affects their quality of life;
  9. The participants must have good compliance and be able to cooperate with the completion of the assessment items of the trial; For participants with reproductive potential and their partners, they must be free from pregnancy plans for at least 2 weeks before the screening to at least 1 year after the administration of the drug, and must agree to take effective non-drug contraceptive measures during the trial (such as condoms, non-drug intrauterine devices, etc.), except for those who have taken permanent contraceptive measures, such as bilateral tubal ligation, vasectomy, etc.

Exclusion Criteria:

If the subjects meet any of the following criteria, they will not be included in this study:

  1. Allergic to the study drug or its excipients, or allergic to similar drugs of the study drug, or have a history of severe allergies (including any food allergy or drug allergy);
  2. Have a previous history of mental disorders, serious diseases, or other significant diseases that may affect safety;
  3. Have a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), or acquired immunodeficiency syndrome-related diseases, or positive HIV serological test results;
  4. Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody positive;
  5. Previously diagnosed with secondary or atypical Parkinson's syndrome caused by drugs, metabolic disorders, or other reasons;
  6. Previously diagnosed with epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological diseases;
  7. Have new or unstable mental symptoms within 1 year before screening (such as mental confusion, severe depression, or tendencies towards self-harm/suicide);
  8. Have a history of dementia or severe cognitive dysfunction; or have obvious dementia or cognitive dysfunction at screening; the 1.1 part of the MDS-UPDRS score at screening is > 3; due to dementia, the subject's compliance is affected, diary cannot be accurately recorded, and/or the informed consent cannot be signed;
  9. Have other serious systemic diseases at the time of screening;
  10. Have any history of malignant tumors in the past;
  11. Are participating in other clinical trials, or have participated in other clinical studies within 3 months before administration and received intervention treatment;
  12. Have active infections at the screening period, and still need systemic application of antibiotics, antifungal, antiviral treatment at baseline and the infection has not been controlled;
  13. Have a history of stroke, unstable angina pectoris, or myocardial infarction attack within 6 months before screening;
  14. Have a history of schizophrenia or other severe mental disorders, drug or alcohol abuse;
  15. Pregnant or lactating women; Subjects deemed unsuitable for participation in the study by the investigator's comprehensive assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Human-derived stromal cells
Administer human matrix cells by intravenous infusion or nasal drip once every two weeks, for a total of 5 administrations.
Biological: Human-derived stromal cells
The human-derived stromal cells were administered intravenously once every two weeks, for a total of 5 times. Among them, half of the subjects (10 people) received intranasal administration of human-derived stromal cells once a day, in the morning and evening, from the 6th to the 8th day after each administration; the remaining subjects (10 people) received nasal administration of placebo once a day, in the morning and evening, from the 6th to the 8th day after each administration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From baseline up to 48 weeks

The safety and tolerability of hUC-MSCs will be assessed by monitoring the frequency of all adverse events (AEs) and serious adverse events (SAEs).

Measure: Number of participants with AEs and SAEs
From baseline up to 48 weeks
Severity of Adverse Events
Time Frame: From baseline up to 48 weeks

Severity of AEs and SAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.

Measure: Grade on NCI-CTCAE v5.0 scale
From baseline up to 48 weeks
Safety Assessments: Vital Signs
Time Frame: From baseline up to 48 weeks

Changes in vital signs including body temperature, heart rate, blood pressure, and oxygen saturation.

Measure: Number of participants with clinically significant changes in vital signs
From baseline up to 48 weeks
Safety Assessments: Laboratory Parameters
Time Frame: From baseline up to 48 weeks

Changes in laboratory tests including complete blood count, coagulation profile, liver and kidney function, BNP, D-dimer, and serum troponin.

Measure: Number of participants with clinically significant abnormal laboratory values
From baseline up to 48 weeks
Safety Assessments: Physical Examination
Time Frame: From baseline up to 48 weeks
Findings from physical examinations, including skin lesions/rashes. Measure: Number of participants with clinically significant physical examination findings
From baseline up to 48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Motor Function as Assessed by MDS-UPDRS Part III
Time Frame: Baseline, 4, 16, 28, and 48 weeks

Change in severity of motor symptoms (e.g., tremor, rigidity, bradykinesia) using the MDS-UPDRS Part III score.

Measure: Score on MDS-UPDRS Part III
Baseline, 4, 16, 28, and 48 weeks
Change in Disease Staging as Assessed by Hoehn & Yahr Staging
Time Frame: Baseline, 4, 16, 28, and 48 weeks
Change in disease stage using the Hoehn & Yahr Staging scale. Measure: Stage on Hoehn & Yahr scale
Baseline, 4, 16, 28, and 48 weeks
Change in Non-Motor Symptoms as Assessed by NMSS
Time Frame: Baseline, 4, 16, 28, and 48 weeks
Change in non-motor symptoms using the Non-Motor Symptoms Scale (NMSS). Measure: Score on NMSS
Baseline, 4, 16, 28, and 48 weeks
Change in Depressive Symptoms as Assessed by HAMD
Time Frame: Baseline, 4, 16, 28, and 48 weeks

Change in depressive symptoms using the Hamilton Depression Rating Scale (HAMD).

Measure: Score on HAMD
Baseline, 4, 16, 28, and 48 weeks
Change in Anxiety Symptoms as Assessed by HAMA
Time Frame: Baseline, 4, 16, 28, and 48 weeks
Change in anxiety symptoms using the Hamilton Anxiety Rating Scale (HAMA). Measure: Score on HAMA
Baseline, 4, 16, 28, and 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LNMDTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified individual participant data in this study (including demographic information, baseline characteristics, all efficacy and safety endpoints, imaging assessment data, etc.).

Related documents: The research plan, statistical analysis plan, informed consent form, and summary of the clinical research report will also be provided.

Data availability: The data will be made available 6 months after the publication of the primary endpoint results of this study in a peer-reviewed journal, and will be maintained for a period of 5 years.

Access Conditions: Data access rights will be granted to those researchers who submit proposals for conducting approved, scientifically sound meta-analyses or for other research purposes. Proposals should be sent to [specified email address or data access committee]. Requesters are required to sign a data usage agreement.

Mechanism: The data will be provided through a controlled-access data warehouse .

IPD Sharing Time Frame

Start date: Available within 6 months after the publication of the main results paper of this trial.

End time: At least 5 days from the date of sharing commencement.

IPD Sharing Access Criteria

Data access rights will be granted to those researchers who submit proposals for conducting approved, scientifically sound meta-analyses or for other research purposes. Proposals should be sent to [406083722@@qq.com]. Requesters are required to sign a data usage agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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