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

Last updated: February 16, 2023
Sponsor: Shanghai East Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Parkinson's Disease

Treatment

N/A

Clinical Study ID

NCT05691114
SA-HAES-102
  • Ages 40-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 orother 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

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 brainstimulation, 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 majorsurgery 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, ischemicheart disease, congestive heart failure, significant arrhythmias or cardiac conductionblock
  11. poorly controlled hypertension, diabetes mellitus, or comorbid endocrine systemdisorders, 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 ofnormal, blood urea nitrogen (BUN) or creatinine(Cr) are less than 1.5 times the upperlimit of normal, or serum albumin < 30.0 g/L
  14. abnormalities in hematologic test: coagulation disorders or ongoing anticoagulationtherapy; 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, whoare unwilling to take contraception during the trial
  18. pregnant or lactating females
  19. other conditions deemed by the investigator to be inappropriate for enrollment.

Study Design

Total Participants: 18
Study Start date:
February 01, 2023
Estimated Completion Date:
February 28, 2026

Study 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).

Connect with a study center

  • Shanghai East Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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