Trials / Withdrawn
WithdrawnNCT01238315
Safety and Efficacy Study of HuCNS-SC in Subjects With Neuronal Ceroid Lipofuscinosis
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- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- StemCells, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 6 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HuCNS-SC | Surgery to implant human CNS stem cells |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2010-11-10
- Last updated
- 2015-01-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01238315. Inclusion in this directory is not an endorsement.