Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608355
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-14
Brief Title:
The Safety Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Study to Assess the Safety Tolerability and Preliminary Efficacy of NouvNeu001 Injection in the Treatment of Early-onset Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinsons Disease EOPD patients It will also learn about the effects of NouvNeu001 treatment The main questions it aims to answer are
What medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery Does injection of NouvNeu001 improve the motor function and non-motor function in participants
Participants will
Be injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery
Take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks
What medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery Does injection of NouvNeu001 improve the motor function and non-motor function in participants
Participants will
Be injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery
Take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None