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

NCT05691114 | Recruiting Phase 1

• 1 other identifier: SA-HAES-102
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Idiopathic Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity (DLT)

  The occurrence of DLT.

  12 months

• 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 Outcomes (9)

• Change from baseline in the UPDRS-III (Unified Parkinson's Rating Scale part III/motor part) scores

  12 months

• Change from baseline in the UPDRS off-time total scores

  12 months

• Change from baseline in the UPDRS on-time total scores

  12 months

• Change from baseline in sum of the UPDRS-II and UPDRS-III scores

  12 months

• Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) scores

  12 months

Study Arms (1)

hAESCs treatment

EXPERIMENTAL

hAESCs will be administration through Ommaya reservoir implanted into the lateral ventricle. The tolerability, safety, and efficacy will be examined of 4 monthly doses of hAESCs for 3 months followed by 2 doses every 3 months in dose escalation through 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).

Biological: hAESCs

Interventions

hAESCs BIOLOGICAL

human Amniotic Epithelial Stem Cells

hAESCs treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, with more than 5 years of idiopathic PD history
• UPDRS-III off-time scores ≤49
• MMSE scores ≥24
• HAMD-17 scores \< 25
• H-Y on-time scores ≤4
• reactive to levodopa or dopa agonists
• PD medication dose is stable for more than 2 months
• no general anesthesia contraindications, no stereotactic surgery contraindications or other conditions that interfere with clinical evaluation
• no abnormalities affecting cell transplantation by cranial MRI
• no participation of other clinical trials 3 months before signing the informed consent

You may not qualify if:

• secondary PD or Parkinson's syndrome
• subcutaneous apomorphine treatment
• scoring ≥ 2 on UPDRS-I item 2, or ≥ 2 on UPDRS-II item 13; or ≥ 3 on UPDRS-II item14
• history of intracranial surgery or device implantation, including deep brain stimulation, within 2 years prior to signing informed consent
• history of seizures or prophylactic application of antiepileptic drugs
• other serious central nervous system disorders
• history of stem cell therapy
• 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
• autoimmune disease or current use of Immunosuppressants
• subjects with comorbid cardiac disease, for example, but not limited to, ischemic heart disease, congestive heart failure, significant arrhythmias or cardiac conduction block
• poorly controlled hypertension, diabetes mellitus, or comorbid endocrine system disorders, pulmonary disorders, gastrointestinal system disorders, serious infections, malignancies, etc.
• positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or Treponema pallidum antibody
• 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
• abnormalities in hematologic test: coagulation disorders or ongoing anticoagulation therapy; moderate to severe anemia; platelet count \< 80 × 10\^9/L
• inability to undergo MRI and positron emission tomography (PET) examinations

Sponsors & Collaborators

• Shanghai East Hospital: lead
• Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China: collaborator

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jingwen Wu, M.D.

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingwen Wu, M.D.

CONTACT

021-38804518; wujingwendongfang@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)