Transplanting human stem cells into the brain for Parkinson's disease
Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease
This study is testing if transplanting human stem cells into the brain can help people with Parkinson's disease feel better and slow down the progression of their symptoms.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai East Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05691114 on ClinicalTrials.gov |
What this trial studies
This is a single-center, single-arm, dose escalation study aimed at exploring the safety, tolerability, and efficacy of human amniotic epithelial stem cells (hAESCs) for patients with idiopathic Parkinson's disease. Participants will receive hAESCs through an Ommaya reservoir implanted into the lateral ventricle of the brain. The study will involve a dose escalation followed by an exploratory expansion phase with three different dosing cohorts. The goal is to assess how these stem cells can impact the progression of Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-70 with more than 5 years of idiopathic Parkinson's disease history and stable medication regimens.
Not a fit: Patients with secondary Parkinson's disease or those who have had recent intracranial surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option that may improve symptoms and quality of life for patients with Parkinson's disease.
How similar studies have performed: While this approach is novel, similar studies involving stem cell therapies for neurodegenerative diseases have shown promising results.
Eligibility criteria
Show full 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.
Where this trial is running
Shanghai, Shanghai
- Shanghai East Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jingwen Wu, M.D. — Shanghai East Hospital
- Study coordinator: Jingwen Wu, M.D.
- Email: wujingwendongfang@163.com
- Phone: 021-38804518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.