Status:
WITHDRAWN
Safety and Efficacy Study of HuCNS-SC in Subjects With Neuronal Ceroid Lipofuscinosis
Lead Sponsor:
StemCells, Inc.
Conditions:
Neuronal Ceroid Lipofuscinosis
Eligibility:
All Genders
6-6 years
Phase:
PHASE1
Brief Summary
The purpose of this Phase Ib study is to determine if "Human Central Nervous System Stem Cells"(HuCNS-SC) is safe to be transplanted in subjects with infantile and late infantile neuronal ceroid lipof...
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.
Eligibility Criteria
Inclusion
- Age 6 months to 6 years
- Male or female
- Clinical diagnosis of Infantile neuronal ceroid lipofuscinosis or late infantile neuronal ceroid lipofuscinosis
- CLN1 or CLN2 mutation
Exclusion
- Previously received an organ, tissue or bone marrow transplantation
- Previously participated in any gene or cell therapy study
- Infection with hepatitis virus, cytomegalovirus, Epstein-Barr virus, or Human Immunodeficiency Virus (HIV)
- Current or prior cancer
- Bleeding disorder
- Unable to have an MRI scan
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01238315
Start Date
November 1 2010
End Date
April 1 2011
Last Update
January 15 2015
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239