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Clinical Trials in China / NCT05901818
Recruiting Phase 1

Safety and Efficacy of Autologous iNSC-DAP in the Treatment of Parkinson's Disease

NCT05901818 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Phase 1
Started
2021-04-01
Last updated
2026-07-01

Condition(s) studied

Parkinson's Disease

Investigational drug(s) / intervention(s)

Autologous induced neural stem cell-derived DA precursor cells

Autologous induced neural stem cell-derived DA precursor cells: The autologous induced neural stem cell-derived DA precursor cells will be stereotactically implanted into the striatum of PD patients.

Study summary

This is a phase I, interventional, single arm, open-label, clinical study to evaluate the safety and efficacy of the striatal transplantation of autologous induced neural stem cell-derived DA precursor cells in Parkinson's Disease patients.

Eligibility

Sex
ALL
Min age
30 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: Ages between 30 and 85 years, males or females; Diagnosed to be Parkinson's disease patients according to MDS Parkinson's disease diagnostic criteria; Disease history over 3 years; Hoehn and Yahr Stage less than or equal to 4 during the medication "on" time; Responsive to levodopa treatment (Maximum rate of improvement in MDS-UPDRS, part 3, is over 30%). Exclusion Criteria: Atypical Parkinsonian syndrome or secondary Parkinsonian syndrome; Accompanied with other central nervous system diseases; With other severe systemic diseases or dysfunction; With severe psychiatric disorders; Subjects are using hormone or cytotoxic drugs and cannot stop taking the drug during the trial; With cognitive disorders (MMSE\<24); With severe dyskinesia (MDS-UPDRS part 4, score in 4.1/4.2 ≥ 2); Subjects have undergone previous brain surgery; Subjects are long-term user of anticoagulant; Subjects have intracranial lesions which may affect the surgery or follow-up studies as assessed by imaging; Subjects are unable to undergo MRI or AV133 PET examination; Pregnancy or in preparation for pregnancy; Not suitable to participate in this clinical trial as assessed by the study investigators/physicians.

Primary outcome measure(s)

  • Assessment of changes during the medication "off" time in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values. — Within 12 months post-transplantation
    Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.
  • Incidence and severity of transplant-related adverse events. — Within 12 months post-transplantation

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital Capital Medical University Beijing Beijing Municipality Recruiting

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Other trials for the same condition

Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease Recruiting
Study on Artificial Intelligence-Based Facial and Speech-Related Patterns in Parkinson's Disease and Their Digital Biomarkers Recruiting
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study Active, not recruiting
Etiology-Phenotype-Outcome Pathway Study on Freezing of Gait (FOG) Recruiting
Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and Parkinsonian Syndromes: Effects and Target Exploration Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05901818 on ClinicalTrials.gov ↗ ← All trials in China