Ignite Creation Date:
2024-05-05 @ 11:02 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01238315
Status:
WITHDRAWN
Last Update Posted:
2015-01-15
First Post:
2010-11-05
Brief Title:
Safety and Efficacy Study of HuCNS-SC in Subjects With Neuronal Ceroid Lipofuscinosis
Sponsor:
StemCells Inc
Organization:
StemCells Inc
Study Overview
Official Title:
A Phase Ib Study of the Safety and Preliminary Efficacy of Allogeneic Intracerebral Human Central Nervous System Stem Cell Transplantation in Subjects With Non-Refractory Infantile and Late Infantile Neuronal Ceroid Lipofuscinosis
Status:
WITHDRAWN
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of timely patient accrual
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 Phase Ib study is to determine if Human Central Nervous System Stem CellsHuCNS-SC is safe to be transplanted in subjects with infantile and late infantile neuronal ceroid lipofuscinosis The study will also measure post-transplantation disease progression
Detailed Description:
Participation in this study will involve screening assessments surgery to implant HuCNS-SC medication to suppress immune system and a series of follow-up assessments
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