Last updated: February 16, 2023
Sponsor: Shanghai East Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Parkinson's Disease
Treatment
N/AClinical Study ID
NCT05691114
SA-HAES-102
Ages 40-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 40-70 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 orother 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
Exclusion
Exclusion Criteria:
- 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 brainstimulation, 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 majorsurgery 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, ischemicheart disease, congestive heart failure, significant arrhythmias or cardiac conductionblock
- poorly controlled hypertension, diabetes mellitus, or comorbid endocrine systemdisorders, 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 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
- abnormalities in hematologic test: coagulation disorders or ongoing anticoagulationtherapy; moderate to severe anemia; platelet count < 80 × 10^9/L
- inability to undergo MRI and positron emission tomography (PET) examinations
- subject with severe allergies
- women of childbearing potential (WOCBP) or subject is a man with a WOCBP partner, whoare unwilling to take contraception during the trial
- pregnant or lactating females
- 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
Connect with a study center
Shanghai East Hospital
Shanghai, Shanghai 200000
ChinaActive - Recruiting

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