Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344026
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-19
First Post:
2024-03-18
Brief Title:
Phase 12a Study of ANPD001 in Parkinson Disease
Sponsor:
Aspen Neuroscience
Organization:
Aspen Neuroscience
Study Overview
Official Title:
Phase 12a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASPIRO
Brief Summary:
This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease All participants will have ANPD001 cells manufactured from their own previously collected cells
Detailed Description:
Participants will undergo a surgical implantation of cells that will mature into dopamine-producing neurons under general anesthesia into a part of the brain where dopamine production is decreased in patients with Parkinson Disease The effect on Parkinson Disease symptoms safety and tolerability and cell survival are assessed for 5 years post-transplant with MRI and PET imaging scans of the brain Safety and tolerability are assessed annually for an additional 10 years via telephone call total follow-up of 15 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None