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

Parkinson's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03119636
• Other study ID #: ChineseASZQ-003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 6, 2017
• Last updated: April 13, 2017
• Start date: May 2017
• Est. completion date: December 2020

Study information

• Verified date: September 2016
• Source: Chinese Academy of Sciences
• Contact: Wang Liu, Doctor
• Phone: +86-01064807858
• Email: wangliu[@]ioz.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Biological:
• NPC transplantation
The cells are stereotactically implanted in the striatum.

Drug:
• Levodopa
Levodopa is used depending on the patient's condition

Locations

Country	Name	City	State
China	The first affiliated hospital of Zhengzhou university	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs), severe TEAEs as assessed by head MRI and blood examination	Number of subjects with adverse events such as the evidence of graft failure or rejection	6 months
Secondary	Change in Unified Parkinson's Disease Rating Scale (UPDRS) score from baseline	The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.	Baseline and 12 months
Secondary	Change in DATscan from baseline	DATscan is an imaging technology that uses small amounts of a radioactive drug to help determine how much dopamine is available in a person's brain.Its principle is based on using of radiopharmaceutical, which bind to dopamine transporters (DAT).	Baseline and 12 months
Secondary	Change in Hoehn and Yahr Stage from baseline	The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress mainly by observing balance and walk.	Baseline and 12 months