Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease

Idiopathic Parkinson's Disease Clinical Trial

Official title:

Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691114
• Other study ID #: SA-HAES-102
• Status: Recruiting
• Phase: Phase 1
• Start date: February 2023
• Est. completion date: February 2026

Study information

• Verified date: February 2023
• Source: Shanghai East Hospital
• Contact: Jingwen Wu, M.D.
• Phone: 021-38804518
• Email: wujingwendongfang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, single-arm, dose escalation study, to explore the safety, tolerability and efficacy of human amniotic epithelial stem cells (hAESCs) for idiopathic Parkinson's disease (PD).

Description:

hAESCs will be administration through the Ommaya reservoir implanted into the lateral ventricle of subjects with idiopathic PD.

This dose escalation will be followed by an exploratory expansion phase in 3 cohorts.

• Dose A (5×10^7 cells/dose)

• Dose B (1.0×10^8 cells/dose)

• Dose C (1.5×10^8 cells/dose).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 40-70 years old, with more than 5 years of idiopathic PD history

2. UPDRS-III off-time scores =49

3. MMSE scores =24

4. HAMD-17 scores < 25

5. H-Y on-time scores =4

6. reactive to levodopa or dopa agonists

7. PD medication dose is stable for more than 2 months

8. no general anesthesia contraindications, no stereotactic surgery contraindications or other conditions that interfere with clinical evaluation

9. no abnormalities affecting cell transplantation by cranial MRI

10. no participation of other clinical trials 3 months before signing the informed consent

Exclusion Criteria:

1. secondary PD or Parkinson's syndrome

2. subcutaneous apomorphine treatment

3. scoring = 2 on UPDRS-I item 2, or = 2 on UPDRS-II item 13; or = 3 on UPDRS-II item14

4. history of intracranial surgery or device implantation, including deep brain stimulation, within 2 years prior to signing informed consent

5. history of seizures or prophylactic application of antiepileptic drugs

6. other serious central nervous system disorders

7. history of stem cell therapy

8. subject who had undergone a major surgery within 3 months and will undergo a major surgery within the next 6 months prior to signing informed consent

9. autoimmune disease or current use of Immunosuppressants

10. subjects with comorbid cardiac disease, for example, but not limited to, ischemic heart disease, congestive heart failure, significant arrhythmias or cardiac conduction block

11. poorly controlled hypertension, diabetes mellitus, or comorbid endocrine system disorders, pulmonary disorders, gastrointestinal system disorders, serious infections, malignancies, etc.

12. positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or Treponema pallidum antibody

13. abnormalities in liver or kidney function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) is less than 2.5 times the upper limit of normal, blood urea nitrogen (BUN) or creatinine(Cr) are less than 1.5 times the upper limit of normal, or serum albumin < 30.0 g/L

14. abnormalities in hematologic test: coagulation disorders or ongoing anticoagulation therapy; moderate to severe anemia; platelet count < 80 × 10^9/L

15. inability to undergo MRI and positron emission tomography (PET) examinations

16. subject with severe allergies

17. women of childbearing potential (WOCBP) or subject is a man with a WOCBP partner, who are unwilling to take contraception during the trial

18. pregnant or lactating females

19. other conditions deemed by the investigator to be inappropriate for enrollment.

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Biological:
• hAESCs
human Amniotic Epithelial Stem Cells

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai East Hospital	Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)	The occurrence of DLT.	12 months
Primary	Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest (AESI)	According to CTCAE V5.0, AE, SAE and AESI evaluated by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions.; AESI is defined as intracranial infection, hemorrhage, rejection, edema, as well as acute allergic reactions and ectopic mass formation associated with the therapy.	12 Months
Secondary	Change from baseline in the UPDRS-III (Unified Parkinson's Rating Scale part III/motor part) scores	UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability	12 months
Secondary	Change from baseline in the UPDRS off-time total scores	UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability	12 months
Secondary	Change from baseline in the UPDRS on-time total scores	UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability	12 months
Secondary	Change from baseline in sum of the UPDRS-II and UPDRS-III scores	UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability	12 months
Secondary	Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) scores	The PDQ-39 is a self-completed questionnaire assessing how often people with Parkinson's experience difficulties across 8 dimensions of daily living with 39 questions . Questions are answered using a 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each scores range from 0 = never have difficulty to 100 = always have difficulty.The higher the score, the lower the quality of life of PD patients.	12 months
Secondary	Changes in the Hamilton Depression-17 (HAMD-17) Scale scores	The HAMD-17 Scale is the most widely used scale in clinical evaluation of depression in PD patients. This project takes 8 points as the critical value of depression, and the total score over 35 points is considered as severe depression, more than 20 points is likely to be diagnosed with depression, less than 8 points is not depressed.	12 months
Secondary	Change from baseline in the Parkinson's Disease Sleep Scale (PDSS) scores	The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance overall quality of night's sleep (item 1), sleep onset and maintenance insomnia (items 2 and 3), nocturnal restlessness (items 4 and 5), nocturnal psychosis (items 6 and 7), nocturia (items 8 and 9), nocturnal motor symptoms (items 10-13), sleep refreshment (item 14) and daytime dozing (item 15). Scores range from 0 (poorly or often) to 10 (very good or never), with a total score of <90 indicating sleep disturbance, with higher scores indicating better sleep quality.	12 months
Secondary	Changes from baseline in the Hoehn and Yahr scale (H-Y)	The Hoehn and Yahr scale is used to provide a general estimate of clinical function of PD patients, combining functional deficits (disability) and objective signs (impairment). The Hoehn and Yahr score ranges from 0 to 5, with higher score indicating higher dysfunction of PD patients.	12 months
Secondary	Changes from baseline in the Mini-Mental State Examination (MMSE)	The total score of tne MMSE ranges from 0 to 30, with a higher score indicating better function for Cognitive assessment.	12 months