Clinical Research on Stem Cell Therapy for Parkinson's Disease

NCT07232147 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: LNMDTC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parkinson Disease (PD); Neurodegenerative Diseases; Movement Disorders

Keywords

Parkinson's disease(PD); Umbilical cord mesenchymal stem cells (hUC-MSCs); Stem cell therapy; Safety and efficacy

Outcome Measures

Primary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  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

  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

  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

  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

  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 Outcomes (5)

• Change in Motor Function as Assessed by MDS-UPDRS Part III

  Baseline, 4, 16, 28, and 48 weeks

• Change in Disease Staging as Assessed by Hoehn & Yahr Staging

  Baseline, 4, 16, 28, and 48 weeks

• Change in Non-Motor Symptoms as Assessed by NMSS

  Baseline, 4, 16, 28, and 48 weeks

• Change in Depressive Symptoms as Assessed by HAMD

  Baseline, 4, 16, 28, and 48 weeks

• Change in Anxiety Symptoms as Assessed by HAMA

  Baseline, 4, 16, 28, and 48 weeks

Study Arms (1)

Human-derived stromal cells

EXPERIMENTAL

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

Interventions

Human-derived stromal cells BIOLOGICAL

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.

Human-derived stromal cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants must meet all of the following criteria to be included in this study:
• The participants must fully understand and comply with the research procedures, voluntarily participate in the study and sign the informed consent form;
• 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;
• 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);
• 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;
• During the screening, the score of the third part of the MDS-UPDRS in the "off" period must be greater than 30;
• 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;
• During the screening, the participants must have a response to levodopa treatment, and the levodopa loading test must be positive;
• The participants must experience a decline in the efficacy of anti-Parkinson's disease treatment, which affects their quality of life;
• 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.

You may not qualify if:

• If the subjects meet any of the following criteria, they will not be included in this study:
• 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);
• Have a previous history of mental disorders, serious diseases, or other significant diseases that may affect safety;
• 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;
• Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody positive;
• Previously diagnosed with secondary or atypical Parkinson's syndrome caused by drugs, metabolic disorders, or other reasons;
• Previously diagnosed with epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological diseases;
• Have new or unstable mental symptoms within 1 year before screening (such as mental confusion, severe depression, or tendencies towards self-harm/suicide);
• 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;
• Have other serious systemic diseases at the time of screening;
• Have any history of malignant tumors in the past;
• Are participating in other clinical trials, or have participated in other clinical studies within 3 months before administration and received intervention treatment;
• 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;
• Have a history of stroke, unstable angina pectoris, or myocardial infarction attack within 6 months before screening;
• Have a history of schizophrenia or other severe mental disorders, drug or alcohol abuse;

Sponsors & Collaborators

• Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.: lead

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.