Safety and Efficacy Study of HuCNS-SC in Subjects With Neuronal Ceroid Lipofuscinosis

Withdrawn before enrolling · Phase 1

Conditions studied: Neuronal Ceroid Lipofuscinosis

In brief

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 lipofuscinosis. The study will also measure post-transplantation disease progression.

Key facts

Study ID

NCT01238315

Run by

StemCells, Inc.

People needed

0

Starts

2010-11-01

Expected to finish

2011-04-01

Last updated by the study team

2015-01-15

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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