Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422208
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-22
First Post:
2024-05-15
Brief Title:
Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinsons Disease
Sponsor:
Penelope J Hallett PhD
Organization:
Mclean Hospital
Study Overview
Official Title:
A Phase 1 Clinical Trial of Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinsons Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
None
Brief Summary:
This research study is evaluating an investigational cell product called autologous induced pluripotent stem cell iPSC-derived dopamine neurons This research study is a single-center Phase 1 clinical trial which will test the safety of injecting the investigational cell product into the brain of subjects with Parkinsons disease
Detailed Description:
The goal of this research study is to test a new treatment for Parkinsons disease Parkinsons disease is a progressive disease that causes people to lose specific brain cells called midbrain dopamine neurons When these dopamine neurons are lost it leads to a lack of dopamine in the brain When there is not enough dopamine people with Parkinsons disease experience problems with their movement This trial will test whether new dopamine neurons made from blood cells from subjects with Parkinsons disease are safe when surgically injected into the area of the brain affected called the putamen of the same subjects called autologous transplantation The trial will assess the safety of the injected cells and will also measure the effects of the transplanted autologous dopamine neurons on Parkinsons disease symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01NS109463 | NIH | None | httpsreporternihgovquickSearchU01NS109463 |