Actively Recruiting
Phase I/II Study to Evaluate Safety, Tolerability, and Efficacy of XS411 Stem Cell Injection for Early-onset Parkinson's Disease
Led by XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · Updated on 2025-12-29
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of XS411 in treating Early-onset Parkinson's Disease (EOPD) through a Phase I/II clinical study. The study includes two phases: Phase I uses a single-arm, open-label dose-escalation design to assess safety and find the recommended dose, while Phase II is a randomized, double-blind, sham-controlled trial to further assess efficacy and safety. This research aims to better understand how XS411 may impact EOPD symptoms and progression. In Phase I, 6 to 12 patients receive a single injection of XS411 at one of two dose levels, followed by at least 28 days of observation for safety concerns. Phase II plans to enroll 81 patients randomly assigned in a 2:1 ratio to either receive XS411 at the recommended dose plus immunosuppressants or a sham procedure plus sham immunosuppressants. This phase will evaluate the treatment's effects over time compared to the control group. Participants will be involved in regular assessments including clinical evaluations, questionnaires such as MDS-UPDRS and Hoehn-Yahr scales, and PET-CT scans to monitor changes in dopamine system function. Follow-up visits occur at 28 days, 3, 6, 9, and 12 months after treatment to monitor safety and preliminary effectiveness. The primary outcome focuses on safety and tolerability 28 days after administration, with secondary outcomes assessing symptom changes and brain imaging results during one year of follow-up.
CONDITIONS
Brief Title
Clinical Study to Evaluate XS411 in Treatment of Early-onset Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of onset between 18 and 50 years with diagnosed Early-onset Parkinson's Disease according to MDS 2015 criteria
- Age at enrollment between 18 and 70 years, any gender
- Disease duration of at least 5 years
- Modified Hoehn-Yahr grade in off-phase between 3 and 4 for Phase I, and between 2 and 4 for Phase II; on-phase grade 3 or less
- Off-period MDS-UPDRS-III score greater than 30
- Positive L-dopa stress test
- Unable to control motor fluctuations adequately with stable medication doses as per guidelines
- Stable anti-Parkinson's drug doses for at least 4 weeks before treatment
- Able to undergo surgical anesthesia and brain CT/MRI examinations
- Agree to postpone other elective neurosurgeries during 24-month follow-up
- Agree not to participate in other clinical studies for 24 months after dosing
- Understand and voluntarily consent to study procedures
You will not qualify if you...
- Non-primary Parkinson's Disease or Parkinson's-related syndromes
- Late-stage Parkinson's with severe or unpredictable dyskinesia
- Prior brain surgeries affecting participation or surgical contraindications
- Current treatment with L-dopa intestinal infusion, apomorphine injection, or continuous anti-PD drug infusion
- Recent treatments for dystonia or spasticity within 6 months
- Recent use of glucocorticoids or immunosuppressants within 3 months
- Previous cell therapy
- Electroconvulsive therapy within 30 days before treatment
- Recent vaccinations within 3 months before screening
- History of mental illness or severe suicidal thoughts/attempts
- Active epilepsy or use of anti-epileptic drugs
- History or signs of dementia or severe cognitive impairment
- Severe anxiety at screening
- Brain injuries or abnormalities increasing surgical risk
- Uncontrolled autoimmune diseases
- Severe cardiovascular, cerebrovascular, or systemic diseases
- Severe arthritis, limp, stroke sequelae, osteoporosis, or recent serious trauma
- Malignant tumors or history thereof
- Active bleeding disorders or abnormal coagulation
- Allergies to study drugs
- Pregnant, breastfeeding, or planning pregnancy during study
- Fertile participants must use effective contraception for 24 months after dosing
- Participation in other clinical trials with treatment within 1 month prior
- Poor compliance potential
- Any condition deemed unsafe or affecting study evaluation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive a single injection of XS411 stem cell treatment for early-onset Parkinson's Disease.
Visits on Day 28, Month 3, Month 6, Month 9, and Month 12 for assessments
Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
M
Michael LEE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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