A Phase I/II, Open-Label Study to Assess the Safety and Efficacy of Striatum Transplantation of Human Embryonic Stem Cells-derived Neural Precursor Cells in Patients With Parkinson's Disease
Overview
- Phase
- Phase 1
- Intervention
- NPC transplantation
- Conditions
- Parkinson's Disease
- Sponsor
- Chinese Academy of Sciences
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs), severe TEAEs as assessed by head MRI and blood examination
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will evaluate the safety and efficacy of intracerebral transplantation of human embryonic stem cells-derived neural precursor cells in patients with Parkinson's Disease.
Detailed Description
This study is a Phase I/II, open-label, non randomized clinical trial. The study will enroll 50 patients for cell injection, administering a single dose of neural precursor cells by stereotaxic intra-striatal injection.
Investigators
Qi Zhou
Deputy director of Institute of zoology, Chinese academy of sciences, and vice president of medical school， University of Chinese academy of sciences
Chinese Academy of Sciences
Eligibility Criteria
Inclusion Criteria
- •Primary Parkinson's disease patients，a history over 5 years，females or males;
- •Cannot effectively control the PD or tolerate the side effects of drugs;
- •Hoehn and Yahr Stage 3 or 4 in the off state at screening
- •Age between 50 and 80 years;
- •Dopamine is effective or once;
- •Sign the informed consent
Exclusion Criteria
- •Atypical Parkinsonian syndrome or only having tremor syndrome;
- •Having been done pallidotomy, DBS, striatum or extrapyramidal surgery;
- •Subjects are using apomorphine or anticoagulant;
- •Subjects used immunosuppressant or antipsychotic drugs in last 3 months;
- •Subjects used botulinum toxin, phenol, or other drugs for the treatment of dystonia or muscle cramps in last 6 months;
- •During the period of active epilepsy preventing epilepsy with antiepileptic;
- •Coagulant function abnormality or other obviously abnormal laboratory test results;
- •Having skin basal cell carcinoma or cervical cancer and other pre-cancerous lesions;
- •Subject has a history of chronic alcohol or drug abuse ;
- •Pregnancy or lactation;
Arms & Interventions
NPC transplantation
The patients will receive Levodopa combined with a regular neural precursor cell (NPC) transplantation
Intervention: NPC transplantation
NPC transplantation
The patients will receive Levodopa combined with a regular neural precursor cell (NPC) transplantation
Intervention: Levodopa
HLA-matched NPC transplantation
The patients will receive Levodopa combined with a HLA-matched neural precursor cell (NPC) transplantation
Intervention: NPC transplantation
HLA-matched NPC transplantation
The patients will receive Levodopa combined with a HLA-matched neural precursor cell (NPC) transplantation
Intervention: Levodopa
HLA-non-matched NPC transplantation
The patients will receive Levodopa combined with a HLA-non-matched neural precursor cell (NPC) transplantation
Intervention: NPC transplantation
HLA-non-matched NPC transplantation
The patients will receive Levodopa combined with a HLA-non-matched neural precursor cell (NPC) transplantation
Intervention: Levodopa
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs), severe TEAEs as assessed by head MRI and blood examination
Time Frame: 6 months
Number of subjects with adverse events such as the evidence of graft failure or rejection
Secondary Outcomes
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) score from baseline(Baseline and 12 months)
- Change in DATscan from baseline(Baseline and 12 months)
- Change in Hoehn and Yahr Stage from baseline(Baseline and 12 months)