Trials / Unknown
UnknownNCT05435755
Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.
The Precise Transplantation of Human Amniotic Epithelial Stem Cells Into the Ventricle Through Surgical Robot in the Treatment of Parkinson's Disease.
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Shanghai East Hospital · Academic / Other
- Sex
- All
- Age
- 30 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety of multiple treatments of hAESCs treatments, while exploring the effectiveness of hAESCs treatments for PD.
Detailed description
The study plans to use randomized controlled trial and recruit 12 participants with Idiopathic Parkinson's disease. The trial will be divided into two groups, hAESCs treatment group and control group, each group 6 subjects. Through surgical robot technology, hAESCs will be precisely multiple transplanted into the lateral ventricles, that is two times consolidation hAESCs treatments or placebo were added to the four times basic hAESCs treatments. Therapeutic safety and effectiveness of multiple treatments of hAESCs on PD will be evaluated to further develop the optimal stem cell treatment strategy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | hAESCs treatment | Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease. |
| BIOLOGICAL | placebo (saline) | 2 times placebo (normal saline) injections as control group |
Timeline
- Start date
- 2022-12-02
- Primary completion
- 2023-07-30
- Completion
- 2023-08-30
- First posted
- 2022-06-28
- Last updated
- 2022-10-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05435755. Inclusion in this directory is not an endorsement.