Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03119636
• Date of registration: 06/04/2017
• Prospective Registration: Yes
• Primary sponsor: Chinese Academy of Sciences
• Public title: Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease
• Scientific title: 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
• Date of first enrolment: May 2017
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03119636
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Wang Liu, Doctor

• Name: Zhou Qi, Doctor
• Affiliation: Institute of zoology, Chinese Academy of Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Primary Parkinson's disease patients,a history over 5 years,females or males;

2. Cannot effectively control the PD or tolerate the side effects of drugs;

3. Hoehn and Yahr Stage 3 or 4 in the off state at screening

4. Age between 50 and 80 years;

5. Dopamine is effective or once;

6. Sign the informed consent

Exclusion Criteria:

1. Atypical Parkinsonian syndrome or only having tremor syndrome;

2. Having been done pallidotomy, DBS, striatum or extrapyramidal surgery;

3. Subjects are using apomorphine or anticoagulant;

4. Subjects used immunosuppressant or antipsychotic drugs in last 3 months;

5. Subjects used botulinum toxin, phenol, or other drugs for the treatment of dystonia or
muscle cramps in last 6 months;

6. During the period of active epilepsy preventing epilepsy with antiepileptic;

7. Coagulant function abnormality or other obviously abnormal laboratory test results;

8. Having skin basal cell carcinoma or cervical cancer and other pre-cancerous lesions;

9. Subject has a history of chronic alcohol or drug abuse ;

10. Pregnancy or lactation;

11. Subjects participated in other clinical trials in recent 3 months;

12. Subject is considered as dementia, a serious mental disorder (depression or mania),
and personality or behavioral disorders through cognitive and behavioral test;

13. Cannot cooperate on the research;

14. Severe brain atrophy, or existing brain injury such as cerebral infarction, cerebral
vascular malformation or trauma;

15. Severe systemic diseases;

16. Severe dyskinesia or frequent "OFF" or "ON" states

17. Severe infectious diseases (eg HIV, HCV, HBV, syphilis positive)

18. Not suitable to participate in this clinical trial assessed by other physicians



Age minimum: 50 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Biological: NPC transplantation

Drug: Levodopa

Primary Outcome(s)

Incidence of treatment-emergent adverse events (TEAEs), severe TEAEs as assessed by head MRI and blood examination [Time Frame: 6 months]

Secondary Outcome(s)

Change in Hoehn and Yahr Stage from baseline [Time Frame: Baseline and 12 months]

Change in Unified Parkinson's Disease Rating Scale (UPDRS) score from baseline [Time Frame: Baseline and 12 months]

Change in DATscan from baseline [Time Frame: Baseline and 12 months]

Secondary ID(s)

ChineseASZQ-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The First Affiliated Hospital of Zhengzhou University