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

NCT ID: NCT03119636

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2020-12-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPC transplantation

The patients will receive Levodopa combined with a regular neural precursor cell (NPC) transplantation

Group Type: EXPERIMENTAL

NPC transplantation

Intervention Type: BIOLOGICAL

The cells are stereotactically implanted in the striatum.

Levodopa

Intervention Type: DRUG

Levodopa is used depending on the patient's condition

HLA-matched NPC transplantation

The patients will receive Levodopa combined with a HLA-matched neural precursor cell (NPC) transplantation

Group Type: EXPERIMENTAL

NPC transplantation

Intervention Type: BIOLOGICAL

The cells are stereotactically implanted in the striatum.

Levodopa

Intervention Type: DRUG

Levodopa is used depending on the patient's condition

HLA-non-matched NPC transplantation

The patients will receive Levodopa combined with a HLA-non-matched neural precursor cell (NPC) transplantation

Group Type: EXPERIMENTAL

NPC transplantation

Intervention Type: BIOLOGICAL

The cells are stereotactically implanted in the striatum.

Levodopa

Intervention Type: DRUG

Levodopa is used depending on the patient's condition

Interventions

NPC transplantation

The cells are stereotactically implanted in the striatum.

Intervention Type: BIOLOGICAL

Levodopa

Levodopa is used depending on the patient's condition

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Qi Zhou

Deputy director of Institute of zoology, Chinese academy of sciences, and vice president of medical school， University of Chinese academy of sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhou Qi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Institute of Zoology, Chinese Academy of Sciences

Locations

The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Liu, Doctor

Role: CONTACT

wangliu@ioz.ac.cn

+86-01064807858

Hao Jie, Doctor

Role: CONTACT

haojie@ioz.ac.cn

+86-01062558737

References

Wang YK, Zhu WW, Wu MH, Wu YH, Liu ZX, Liang LM, Sheng C, Hao J, Wang L, Li W, Zhou Q, Hu BY. Human Clinical-Grade Parthenogenetic ESC-Derived Dopaminergic Neurons Recover Locomotive Defects of Nonhuman Primate Models of Parkinson's Disease. Stem Cell Reports. 2018 Jul 10;11(1):171-182. doi: 10.1016/j.stemcr.2018.05.010. Epub 2018 Jun 14.

Reference Type: DERIVED

PMID: 29910127 (View on PubMed)

Other Identifiers

ChineseASZQ-003

Identifier Type: -

Identifier Source: org_study_id