Actively Recruiting
The Safety and Tolerability of XS411CN Injection in Treatment of Primary Parkinson's Disease
Led by XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · Updated on 2025-09-11
12
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
Sponsors
X
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This Phase I clinical trial is designed to evaluate the safety, tolerability of a single dose of XS411 (derived dopaminergic neural progenitor cell injection) in patients with primary Parkinson's disease
CONDITIONS
Official Title
The Safety and Tolerability of XS411CN Injection in Treatment of Primary Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 50 and 75 years old
- Diagnosed with clinically established Parkinson's disease according to MDS criteria
- Diagnosis made at least 5 years ago
- Hoehn-Yahr score between 3 and 4 during off-time
- Average off-time of at least 2.5 hours per day
- Stable anti-Parkinson's therapy for at least 1 month before screening
- Previous anti-Parkinson's treatment was effective but now has declined or caused motor complications
- Positive levodopa challenge test showing more than 30% improvement in motor score
- Completed all recommended vaccinations at least 3 months before administration
- Complete blood count within specified normal ranges (ANC ≥ 2.0×10⁹/L, WBC ≥ 4.0×10⁹/L, PLT ≥ 100×10⁹/L, HGB ≥ 10 g/dL)
- Provided written informed consent or legal guardian consent
You will not qualify if you...
- Parkinsonian syndrome or secondary Parkinson's disease
- Severe disabling peak-dose or biphasic dyskinesia, or unpredictable symptoms in advanced Parkinson's
- Severe cognitive impairment (MMSE < 24) or inability to comply with study procedures
- History of severe mental illness, suicidal tendencies, or recent suicide attempts
- Severe brain abnormalities increasing surgical risk
- Active internal bleeding or recent difficult-to-control bleeding
- Previous striatal or extrapyramidal surgery including deep brain stimulation
- Coagulation abnormalities
- Abnormal liver or kidney function tests
- Use of certain medications including high-dose benzodiazepines, immunosuppressants (except study drugs), antipsychotics, botulinum toxin, phenol, baclofen, or recent cell therapy
- Contraindications to anesthesia, stereotactic surgery, MRI, or PET scans
- Significant cardiovascular diseases or uncontrolled diabetes or hypertension
- Active infections requiring treatment but not controlled
- Severe lung diseases
- Uncontrolled autoimmune diseases
- Severe arthritis, stroke sequelae, severe osteoporosis, or recent severe trauma
- History of malignancy except certain skin and cervical cancers
- Serious infectious diseases
- Pregnancy, breastfeeding, or planning pregnancy during study and 6 months after
- Participation in other clinical trials within 3 months
- History of alcoholism or drug abuse
- Severe allergies to study drugs or immunosuppressants
- Other conditions deemed unsuitable by investigators
- Severe depression or persistent hallucinations after medication optimization
- Previous MRI-guided focused ultrasound thalamotomy
- Use of immunosuppressants within 3 months except those in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
M
Michael LEE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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