Status:
RECRUITING
A Clinical Trial of Parkinson's Disease Treatment by HiPSCs Derived Dopaminergic Neural Precursor Cells
Lead Sponsor:
Shanghai East Hospital
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
XellSmart Biomedical (Suzhou) Co., Ltd. has closely collaborated with Shanghai East Hospital(East Hospital Affiliated To Tongji University) , using iPSC seed cells, on the development and establishmen...
Detailed Description
This study is a non-randomized, open-label, investigator-initiated interventional clinical trial aimed at exploring the safety of stem cell investigational drugs. The study plans to recruit 3 eligible...
Eligibility Criteria
Inclusion
- The patient or their legally authorized guardian consents to participate in this study and signs the Informed Consent Form (ICF) in writing.
- Patients with primary Parkinson's disease, aged between 30 and 70 years, of any gender, with a disease duration of more than 5 years.
- 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.
- 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%.
- Patients who have stably received anti-Parkinson drug therapy for more than 3 months.
- Previous effective treatment with levodopa, followed by significant drug resistance and wearing-off effect.
- 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.
- Head MRI does not reveal structural abnormalities that would affect stem cell transplantation, such as severe brain atrophy or space-occupying lesions.
- 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
- Patients with atypical Parkinson's disease, such as Parkinson's syndrome or secondary Parkinson's disease.
- Patients with Parkinson's disease with only tremors.
- Patients with severe motor impairment preventing the completion of routine motor tasks.
- Patients with severe neurological deficits caused by other diseases.
- Patients with severe psychiatric symptoms or dementia.
- 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.
- Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery.
- Patients with apomorphine treatment currently .
- 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.
- Pregnant or lactating female patients and male and female patients who cannot use effective contraception within 1 year after the last study drug use.
- Patients who have participated in other drug or medical device clinical studies within the last 3 months.
- 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.
- Patients who have history of seizures or prophylactic use of antiepileptic drugs.
- Patients who have contraindications for general anesthesia or stereotactic surgery, such as sleep apnea or chronic obstructive pulmonary disease, etc.
- 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.
- Patients with alcohol or drug abuse.
- Patients who have used a high dose of benzodiazepines within the last 3 months.
- 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.
- History of any malignant tumors.
- 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).
- 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.
- Other situations in which the investigator believes that the subject is not suitable for inclusion or cannot tolerate stem cell transplantation surgery.
- PD subjects found to have gene mutations by genetic testing.
Key Trial Info
Start Date :
November 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 22 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06145711
Start Date
November 23 2023
End Date
December 22 2025
Last Update
October 15 2024
Active Locations (2)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
2
Shanghai East Hospital
Shanghai, Shanghai Municipality, China