General Information |
| Summary |
This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's disease. |
| Description |
This is a multi-center, single arm, and open label trial. The NouvNeu001 will be transplanted into bilateral putamen/striatum using stereotactic neurosurgery. Subjects will take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2024-01-17 |
| End date (estimated) |
2029-07-31 |
| Clinical feature |
| Label |
Parkinson's disease |
| Link |
http://purl.obolibrary.org/obo/DOID_14330 |
| Description |
A synucleinopathy that has_material_basis_in degeneration of the central nervous system that often impairs motor skills, speech, and other functions.; Xref MGI.
OMIM mapping confirmed by DO. [SN]. |
|
Administrative Information |
| NCT number |
NCT06167681 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06167681 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06167681 |
| Public contact |
| Email |
caimeng@iregene.com |
| Public email |
caimeng@iregene.com |
| First name |
Meng |
| Last name |
Cai |
| Phone |
+ 86-027-59337986 |
| Country |
|
|
| Sponsors |
iRegene Therapeutics Co., Ltd.
|
Cells |
| Which differentiated cell type is used |
| Label |
dopaminergic neuron |
| Link |
http://purl.obolibrary.org/obo/CL_0000700 |
| Description |
A neuron that releases dopamine as a neurotransmitter. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
40 |
