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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2023
• Main ID: NCT05691114
• Date of registration: 10/01/2023
• Prospective Registration: Yes
• Primary sponsor: Shanghai East Hospital
• Public title: Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease
• Scientific title: Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease
• Date of first enrolment: February 2023
• Target sample size: 18
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT05691114
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Jingwen Wu, M.D.

• Name: Jingwen Wu, M.D.

• Name: Jingwen Wu, M.D.
• Affiliation: Shanghai East Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 40 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Parkinson's Disease

Intervention(s)

Biological: hAESCs

Primary Outcome(s)

Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest (AESI) [Time Frame: 12 Months]

Dose limiting toxicity (DLT) [Time Frame: 12 months]

Secondary Outcome(s)

Change from baseline in the UPDRS off-time total scores [Time Frame: 12 months]

Change from baseline in the UPDRS on-time total scores [Time Frame: 12 months]

Changes in the Hamilton Depression-17 (HAMD-17) Scale scores [Time Frame: 12 months]

Changes from baseline in the Mini-Mental State Examination (MMSE) [Time Frame: 12 months]

Change from baseline in the UPDRS-III (Unified Parkinson's Rating Scale part III/motor part) scores [Time Frame: 12 months]

Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) scores [Time Frame: 12 months]

Change from baseline in sum of the UPDRS-II and UPDRS-III scores [Time Frame: 12 months]

Change from baseline in the Parkinson's Disease Sleep Scale (PDSS) scores [Time Frame: 12 months]

Changes from baseline in the Hoehn and Yahr scale (H-Y) [Time Frame: 12 months]

Secondary ID(s)

SA-HAES-102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China