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Clinical trial of autologous olfactory mucosa mesenchymal stromal cells in the treatment of Parkinson's disease

Clinical trial of autologous olfactory mucosa mesenchymal stromal cells in the treatment of Parkinson's disease

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100055021
Enrollment
Unknown
Registered
2021-12-30
Start date
2020-01-01
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

Treatment group :Autologous olfactory mucosa mesenchymal stromal cell therapy + routine Parkinson's disease treatment
Control group:Placebo treatment plus routine Parkinson's disease treatment

Sponsors

The Second Affiliated Hospital of Hu'nan Normal University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40-80 years, gender is not limited; 2. Patients currently diagnosed with Parkinson's disease with motor complications (diagnosed by a neurologist), meeting the diagnostic criteria for Parkinson's disease in China in 2016; 3. Sensitivity to levodopa, defined as at least a 33% improvement in the UPDRS motor score during the ''on'' period compared to the ''off'' period; 4. Hoehn-Yahr staging is between 1-5; 5. Head MRI does not suggest brain atrophy or other intracranial lesions; 6. Normal bone marrow hematopoietic function, no bleeding tendency, blood routine: HGB>=90g/L, WBC>4.0x10^9/L (NEU>=1.5x10^9/L), PLT>=100x10^9/L ; 7. Liver function: total bilirubin =80mL/min; 9. There is no evidence of acute inflammatory infection on chest CT; 10. No other serious heart, liver, kidney disease, etc.; 11. No serious viral or bacterial infection; 12. Patients or legal representatives agree to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Highly allergic or have a history of severe allergies; 2. Those with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation; 3. Patients with systemic infection or severe local infection requiring anti-infective treatment; 4. Coagulation disorders (such as hemophilia); 5. Infectious diseases (such as HIV, RPR, active tuberculosis, etc.); 6. Patients with severe autoimmune diseases; 7. The investigator believes that there are other reasons for not being included in the treatment; 8. Received clinical research of other drugs within 3 months before screening; 9. Those who cannot comply with the research requirements; 10. Pregnant or lactating patients.

Design outcomes

Primary

MeasureTime frame
Dopamine Transporter Brain Imaging;Unified Parkinson's Disease Rating Scale;

Countries

China

Contacts

Public ContactZhuo Yi

The Second Affiliated Hospital of Hu'nan Normal University

zhuoyi9195cs@163.com+86 18075136498

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026