Stereotactic Transplantation of hAESCs for Parkinson's Disease

NCT ID: NCT04414813

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-08
• Study Completion Date: 2023-02-08

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of stereotactic transplantation of hAESCs for Parkinson's disease.

Detailed Description

The study plans to recruit 3 participants with Parkinson's disease . Using stereotactic technology, hAESCs will be accurately transplanted into the lateral ventricle. Therapeutic effectiveness and safety of hAESCs on PD will be evaluated. hAESCs are derived from placental amnion donated after cesarean section in healthy women. hAESCs is developed from the epiblast as early as 8 days after fertilization, recent reports indicate that hAESCs have some characteristics of neural stem cell. These cells are able to differentiate into dopaminergic neurons and secrete dopamine and various neurotrophic factors. These HAESCs could be seen as one of the best potential stem cell source for treating Parkinson's disease.

Conditions

Parkinson's Disease

Study Design

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

Study Groups

hAESCs treatment

50 millions hAESCs are transplanted to participants with PD.

Group Type: EXPERIMENTAL

Human Amniotic Epithelial Stem Cells

Intervention Type: BIOLOGICAL

Stereotactic transplantation of hAESCs for participants with PD.

Interventions

Human Amniotic Epithelial Stem Cells

Stereotactic transplantation of hAESCs for participants with PD.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 30-70 years old, with primary Parkinson's disease more than 5 years, male or female;

2. The "off-stage"Hohen and Yahr grade of Parkinson's disease is from 2 to 4; and the"off-stage"UPDRS score is 38-70, difference between two scores before treatment is less than 10% ;

3. The dosage of medicine is stable for more than 3 months;

4. Levodopa treatment was effective ;

5. Stable condition, good control of complications, no general anesthesia contraindications, no contraindications to stereotactic surgery and other conditions that interfere with clinical evaluation;

6. No abnormalities affecting cell transplantation were found through head MRI;

7. Patients shall be properly cared during treatment, and caregivers can provide assistance to the researcher if necessary.

Exclusion Criteria

1. Atypical Parkinson's disease, such as Parkinson's syndrome, secondary Parkinson's disease;

2. Only having tremor syndrome;

3. Serious movement disorders and cannot complete any routine exercise tasks;

4. Symptoms of severe neurological deficits caused by other diseases;

5. Severe mental symptoms or dementia;

6. Patients are unwilling to cooperate or incapable of completing self-evaluation, and cannot complete the evaluator with the help of a doctor;

7. History of striatum or extrapyramidal surgery, including deep brain stimulation (DBS);

8. Ongoing treatment of apomorphine injecting ;

9. Coagulation disorders or ongoing anticoagulation therapy;

10. Women of childbearing age who do not take effective contraception;

11. Pregnant or lactation;

12. Patients who have participated in other clinical studies of drugs or medical devices within 3 months;

13. Botox toxin, phenol, subarachnoid injection of baclofen or interventional therapy for the treatment of dystonia or spasticity within 6 months;

14. History of seizures or taking prophylactic anti-epileptic drugs;

15. General anesthesia or stereotactic surgery contraindications, such as sleep apnea, chronic obstructive pulmonary disease;

16. Other circumstances judged by the investigator that may cause negative effect to the subject;

17. Alcohol or drug abuse;

18. Used diazepam within 3 months;

19. Severe cognitive impairment, depression, or behavioral disorder, defined as the Mini-Mental State Assessment Scale (MMSE) of less than 26 points, and the Hamilton Depression Rating Scale (HAMD) of greater than 35 points;

20. Chest CT shows active disease or tumor;

21. Currently suffering from or ever had a tumor other than cutaneous basal cell tumor and cervical carcinoma in situ;

22. The detection of HIV, hepatitis B virus(HBV), hepatitis C virus (HCV), syphilis and other infection indicators before surgery can not exclude HIV and syphilis infection;

23. Abnormal liver and kidney normal function tests in the laboratory, liver and kidney function is defined as Alanine aminotransferase（ALT）, Aspartate aminotransferase（AST） is less than 2.5 times the upper limit of normal, blood urea nitrogen (BUN) and Creatinine（Cr） are less than the upper limit of normal.

24. Other situations not suitable for enrollment judged by investigator

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WU Jingwen, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital, China

Locations

WU Jingwen

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

DFSC-2019（CR）-001

Identifier Type: -

Identifier Source: org_study_id