Actively Recruiting
A Clinical Trial of Parkinson's Disease Treatment by HiPSCs Derived Dopaminergic Neural Precursor Cells
Led by Shanghai East Hospital · Updated on 2024-10-15
3
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 establishment of a dopaminergic neural precursor cell production system. This study is conducted under collaboration between Shanghai East Hospital and XellSmart Biomedical (Suzhou) Co., Ltd. It is a distinctive stem cell therapy research targeting Parkinson's disease patients, characterized by the following: 1. The first instance in China of using autologous iPSC-derived subtype-specific dopaminergic neural precursor cells for alternative transplantation therapy in Parkinson's disease. 2. Before the initiation of this study, there was only one reported case around the world involving the use of laboratory-grade autologous iPSC-induced dopaminergic neural precursor cells for Parkinson's disease treatment in an American Caucasian individual. Positive preliminary clinical research results were obtained and published in the New England Journal of Medicine in 2020. Since then, no similar studies have been reported. It has great significance to conduct this research. It will fill two critical clinical research gaps in stem cell therapy for Parkinson's disease in the world: 1. The use of clinical-grade autologous iPSCs differentiated into dopaminergic neural cells, and treat Parkinson's disease. 2. Evaluating the safety of using autologous iPSC-differentiated dopaminergic neural cells for Parkinson's disease treatment in individuals of Asian descent or Chinese ethnicity.
CONDITIONS
Official Title
A Clinical Trial of Parkinson's Disease Treatment by HiPSCs Derived Dopaminergic Neural Precursor Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legal guardian consents and signs informed consent
- Diagnosed with primary Parkinson's disease, age 30 to 70 years
- Disease duration longer than 5 years
- Hohen-Yahr stage 3 to 4, or below 3 if refusing other treatments
- MDS-UPDRS-III score during OFF periods greater than 38 and stable before surgery
- Stable anti-Parkinson medication for over 3 months
- Previously effective levodopa treatment with drug resistance and wearing-off
- Stable condition with controlled complications, no contraindications for anesthesia or stereotactic surgery
- Head MRI shows no structural brain abnormalities affecting transplantation
- Has a caregiver able to assist and provide condition information
You will not qualify if you...
- Atypical Parkinson's disease or secondary Parkinson's disease
- Parkinson's disease with only tremors
- Severe motor impairments preventing routine tasks
- Severe neurological deficits from other diseases
- Severe psychiatric symptoms or dementia
- Unwilling or unable to cooperate or complete assessments
- History of pallidotomy, thalamotomy, or deep brain stimulation surgery
- Currently receiving apomorphine treatment
- Coagulation abnormalities or on anticoagulation therapy
- Pregnant, lactating, or unable to use effective contraception for 1 year post-study drug
- Participation in other drug or device clinical studies within last 3 months
- Use of treatments for muscle tone disorders or spasticity in last 6 months
- History of seizures or use of antiepileptic drugs
- Contraindications for anesthesia or stereotactic surgery like sleep apnea or COPD
- Unstable systemic diseases including active infections, poorly controlled hypertension, unstable angina, heart failure, or metabolic diseases
- Alcohol or drug abuse
- High dose benzodiazepine use in last 3 months
- Severe cognitive impairment, depression, or behavioral disorders
- History of malignant tumors
- Active hepatitis A, B, C, E, HIV, or syphilis infections
- Abnormal liver or kidney function tests
- Other conditions making subject unsuitable or intolerant to stem cell transplantation
- Parkinson's disease subjects with gene mutations found by genetic testing
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
2
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
Research Team
W
WU jingwen Shanghai East Hospital
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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