Completed

Clinical Study of Stereotactic Transplantation of Human Amniotic Epithelial Stem Cells (hAESCs) in the Treatment of Parkinson's Disease (PD)

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What is being tested

Human Amniotic Epithelial Stem Cells

Biological
Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

From 30 to 70 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: October 2020
See protocol details

Summary

Principal SponsorShanghai East Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 8, 2020

Actual date on which the first participant was enrolled.

The study plans to recruit 3 participants with Parkinson's disease . Using stereotactic technology, hAESCs will be accurately transplanted into the lateral ventricle. Therapeutic effectiveness and safety of hAESCs on PD will be evaluated. hAESCs are derived from placental amnion donated after cesarean section in healthy women. hAESCs is developed from the epiblast as early as 8 days after fertilization, recent reports indicate that hAESCs have some characteristics of neural stem cell. These cells are able to differentiate into dopaminergic neurons and secrete dopamine and various neurotrophic factors. These HAESCs could be seen as one of the best potential stem cell source for treating Parkinson's disease.

Official TitleClinical Study of Stereotactic Transplantation of Human Amniotic Epithelial Stem Cells (hAESCs) in the Treatment of Parkinson's Disease (PD)
NCT04414813
Principal SponsorShanghai East Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesParkinsonian Disorders

Criteria

7 inclusion criteria required to participate
30-70 years old, with primary Parkinson's disease more than 5 years, male or female;
The "off-stage"Hohen and Yahr grade of Parkinson's disease is from 2 to 4; and the"off-stage"UPDRS score is 38-70, difference between two scores before treatment is less than 10% ;
The dosage of medicine is stable for more than 3 months;
Levodopa treatment was effective ;
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24 exclusion criteria prevent from participating
Atypical Parkinson's disease, such as Parkinson's syndrome, secondary Parkinson's disease;
Only having tremor syndrome;
Serious movement disorders and cannot complete any routine exercise tasks;
Symptoms of severe neurological deficits caused by other diseases;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
50 millions hAESCs are transplanted to participants with PD.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

WU Jingwen

Shanghai, ChinaOpen WU Jingwen in Google Maps
CompletedOne Study Center