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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)

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital Capital Medical University Beijing Beijing Municipality Recruiting

More Xuanwu Hospital, Beijing trials in China

Other trials for the same condition

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