Lack of timely patient accrual
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
Sponsor study identifier
interventional
0
1 country
1
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Actual (reported)Study Completion
April 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
November 5, 2010
Actual (reported)November 10, 2010
Actual (reported)April 2011
Actual (reported)April 2011
Actual (reported)number of participants with adverse events.
Safety will be measured by number of adverse events and changes in neurological status.
one year following transplantation
Number of subjects with improvement in neurological, neuropsychological development, MRI and MRS
one year following transplantation
Surgery to implant human CNS stem cells
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Oregon Health and Science University
Portland, Oregon, 97239, United States
Nathan Selden, MD, PhD
Oregon Health and Science University
0 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2010
First Posted
November 10, 2010
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Longitudinal Assessment of Atypical Tripeptidyl Peptidase 1 Enzyme Deficiency Patients
Contact the study team to confirm eligibility.
Primary Completion
April 2011
Actual (reported)Study Completion
April 2011
Actual (reported)Last Updated
January 15, 2015
Record last verified: 2015-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: