---
title: Reduce medication wearing off symptoms
nct_id: NCT06145711
phase: NA
status: RECRUITING
sponsor: Shanghai East Hospital
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06145711"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06145711"
last_fetched: "2026-05-10T14:08:42.516Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce medication wearing off symptoms

**Goal (in five words):** Reduce medication wearing off symptoms

**Official Title:** A Clinical Trial of Parkinson's Disease Treatment by Human-induced Pluripotent Stem Cells (hiPSCs) Derived Dopaminergic Neural Precursor Cells

**Trial ID:** [NCT06145711](https://clinicaltrials.gov/study/NCT06145711)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Shanghai East Hospital
- **Target Enrollment:** 3 participants
- **Start Date:** 2023-11-23
- **Completion Date:** 2025-12-22
- **Conditions:** Parkinson's Disease
- **Interventions:** hiPSC-DAP
- **Intervention Types:** OTHER

## Summary For Families

It aims to replace the dopamine-producing cells lost in Parkinson's to reduce severe motor symptoms and the levodopa wearing-off that no longer responds well to medication. Surgeons inject dopaminergic neural precursor cells made from human-induced pluripotent stem cells into targeted brain areas using stereotactic surgery, the transplanted cells are intended to mature into dopamine neurons and supply a steadier source of dopamine, potentially lowering reliance on levodopa and smoothing motor fluctuations. Looking for adults 30 to 70 years old with primary Parkinson's for more than 5 years, mostly moderate to advanced disease (Hohen‑Yahr stage 3,4), clear and stable OFF-period motor scores, prior benefit then wearing-off on levodopa, stable meds for 3+ months, and the ability to undergo brain surgery with a caregiver to help.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 70 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

1. The patient or their legally authorized guardian consents to participate in this study and signs the Informed Consent Form (ICF) in writing.
2. Patients with primary Parkinson's disease, aged between 30 and 70 years, of any gender, with a disease duration of more than 5 years.
3. Hohen-Yahr stage for Parkinson's disease (Appendix V) is between stage 3 and stage 4. Patients with a Hohen-Yahr stage below 3 who refuse other treatments may also be included.
4. The MDS-UPDRS-III score for "OFF" periods in Parkinson's disease is greater than 38 points, and the MDS-UPDRS-III score for the two "OFF" periods before surgery is stable, i.e., (high value - low value) / high value is less than or equal to 10%.
5. Patients who have stably received anti-Parkinson drug therapy for more than 3 months.
6. Previous effective treatment with levodopa, followed by significant drug resistance and wearing-off effect.
7. The patient who is in stable condition, well-controlled complications, no contraindications for general anesthesia, no contraindications for stereotactic surgery, and no other conditions that interfere with clinical assessment.
8. Head MRI does not reveal structural abnormalities that would affect stem cell transplantation, such as severe brain atrophy or space-occupying lesions.
9. Subjects have a caregiver and are able to provide information about their condition before and after stem cell transplantation and can assist the investigator if necessary.

Exclusion Criteria:

1. Patients with atypical Parkinson's disease, such as Parkinson's syndrome or secondary Parkinson's disease.
2. Patients with Parkinson's disease with only tremors.
3. Patients with severe motor impairment preventing the completion of routine motor tasks.
4. Patients with severe neurological deficits caused by other diseases.
5. Patients with severe psychiatric symptoms or dementia.
6. The Patient who is unwilling or unable to cooperate, incapable of self-assessment, and unable to complete assessments even with the help of a physician.
7. Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery.
8. Patients with apomorphine treatment currently .
9. Coagulation abnormalities (prothrombin time (PT) or international normalized ratio (INR) \> 1.5×ULN; activated partial thromboplastin time (APTT) \> 1.5×ULN) or receiving anticoagulation therapy.
10. Pregnant or lactating female patients and male and female patients who cannot use effective contraception within 1 year after the last study drug use.
11. Patients who have participated in other drug or medical device clinical studies within the last 3 months.
12. Patients who have used botulinum toxin, phenol, subarachnoid injection of baclofen, or intervention therapy for treating muscle tone disorders or spasticity within the last 6 months.
13. Patients who have history of seizures or prophylactic use of antiepileptic drugs.
14. Patients who have contraindications for general anesthesia or stereotactic surgery, such as sleep apnea or chronic obstructive pulmonary disease, etc.
15. Patients with any other unstable systemic diseases, including active infections, poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg after treatment), unstable angina, congestive heart failure (New York Heart Association NYHA class II or above), or metabolic diseases, etc.
16. Patients with alcohol or drug abuse.
17. Patients who have used a high dose of benzodiazepines within the last 3 months.
18. Patients with severe cognitive impairment, depression, or behavioral disorders, defined as a Mini-Mental State Examination (MMSE) score less than 26 and a Hamilton Depression Rating Scale (HAMD) score greater than 35.
19. History of any malignant tumors.
20. Patients with hepatitis A, active hepatitis B (HBsAg positive with HBV DNA higher than the upper limit of normal, and excluding hepatitis caused by drugs or other reasons), active hepatitis C (anti-HCV antibody positive with HCV RNA higher than the upper limit of normal), hepatitis E, human immunodeficiency virus (HIV) antibody positive, or syphilis (TP antibody positive).
21. Patients with abnormal liver and kidney function laboratory tests during the screening period, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3×ULN, serum creatinine \>1.5×ULN, or total bilirubin \>1.5×ULN.
22. Other situations in which the investigator believes that the subject is not suitable for inclusion or cannot tolerate stem cell transplantation surgery.
23. PD subjects found to have gene mutations by genetic testing.
```

## Locations (2)

- Shanghai East Hospital, Shanghai, Shanghai Municipality, China _(31.2222, 121.4581)_
  - wu jingwen Shanghai East Hospital — (CONTACT) — +13810835976 — songjiwen001@qq.com
- Shanghai East Hospital, Shanghai, Shanghai Municipality, China _(31.2222, 121.4581)_
  - Jingwen Wu — (CONTACT) — 13585517271 — wujingwendongfang@163.com

## Central Contacts

- WU jingwen Shanghai East Hospital — (CONTACT) — +13810835976 — songjiwen001@qq.com

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*Canonical: https://parkinsonspathways.com/trial/NCT06145711*  
*HTML version: https://parkinsonspathways.com/trial/NCT06145711*  
*Source data: https://clinicaltrials.gov/study/NCT06145711*