Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.

NCT ID: NCT05435755

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2023-08-30

Brief Summary

The purpose of this study is to evaluate the safety of multiple treatments of hAESCs treatments, while exploring the effectiveness of hAESCs treatments for PD.

Detailed Description

The study plans to use randomized controlled trial and recruit 12 participants with Idiopathic Parkinson's disease. The trial will be divided into two groups, hAESCs treatment group and control group, each group 6 subjects. Through surgical robot technology, hAESCs will be precisely multiple transplanted into the lateral ventricles, that is two times consolidation hAESCs treatments or placebo were added to the four times basic hAESCs treatments. Therapeutic safety and effectiveness of multiple treatments of hAESCs on PD will be evaluated to further develop the optimal stem cell treatment strategy.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

hAESCs treatment

A total of 6 times hAESCs transplants will be performed. 50 million (in 2ml) hAESCs will be transplanted into the ventricle of participants through the Ommaya sac (set as day 0 at the beginning of the trial). Subsequently, hAESCs ventricle transplants will be performed at 1 month ±5 days, 2 months ±5 days, 3 months ±5 days, 6 months ±5 days, and 9 months ±5 days after the first cell transplantation, with a volume of 50 million cells (in 2 ml) each time.

Group Type: EXPERIMENTAL

hAESCs treatment

Intervention Type: BIOLOGICAL

Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.

Control group

Four times hAESCs transplants and two times placebo (cell preservation solution) injections will be performed by Ommaya sac. 50 million (in 2ml) hAESCs will be transplanted into the ventricle of participants (set as day 0 at the beginning of the trial). Subsequently, hAESCs will be transplanted into the ventricle for 3 times, respectively, at 1 month ±5 days , 2 months±5 days , and 3 months ±5 days after the first cell transplantation, with a volume of 50 million cells (in 2 ml) each time. Ventricle injection of 2 ml placebo (cell preservation solution) will be performed at 6 months ±5 days and 9 months ±5 days after the first cell transplantation.

Group Type: PLACEBO_COMPARATOR

placebo (saline)

Intervention Type: BIOLOGICAL

2 times placebo (normal saline) injections as control group

Interventions

hAESCs treatment

Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.

Intervention Type: BIOLOGICAL

placebo (saline)

2 times placebo (normal saline) injections as control group

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

2. The "off-age" UPDRS exercise score is between 38 and 70 points, two times before the operation, the "down period" UPDRS exercise score was stable, that is, (high value - low value) / high value ≤ 10%;

3. The Parkinson treatment is stable for more than 3 months;

4. Levodopa treatment was effective;

5. 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 the cranial MRI;

7. Patients shall be properly cared during treatment, and caregivers can provide transplantation situations and 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. "off period" or "on period" has 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. Injecting apomorphine treatment;

9. Abnormal blood coagulation 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 prophylactic anti-epileptic drugs;

15. Alcohol or drug abuse;

16. 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;

17. Malignant tumor or active infection within 5 years;

18. Serum virology showed positive results for hepatitis C virus (HCV) , treponema pallidum (TP) or HIV; Active hepatitis B (hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive, and peripheral blood HBV DNA titer ≥1×10^3 IU/ mL);

19. Abnormal liver and kidney 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.

20. Other conditions considered ineligible for inclusion by the 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

Jingwen Wu, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital, China

Locations

Jingwen Wu

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jingwen Wu, Dr

Role: CONTACT

wujingwendongfang@163.com

18916111526

Facility Contacts

Jingwen Wu, Dr

Role: primary

wujingwendongfang@163.com

18916111526

Other Identifiers

2020YFA0112600

Identifier Type: -

Identifier Source: org_study_id