Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-27 @ 1:50 PM
Study NCT ID:
NCT01625559
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD)
Sponsor:
CHABiotech CO., Ltd
Organization:
Study Overview
Official Title:
A Phase I, Open-Label, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial(MA09-hRPE) Cells in Patients With Stargardt's Macular Dystrophy(SMD)
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The purpose of this study is to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD
Detailed Description:
* to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD
* to evaluate the preliminary efficacy of MA09-hPRE in patients with SMD
* to evaluate the preliminary efficacy of MA09-hPRE in patients with SMD
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: