Long-Term Follow-Up Study of Human Stem Cells Transplanted in Subjects With Connatal Pelizaeus-Merzbacher Disease (PMD)
NCT ID: NCT01391637
Last Updated: 2016-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4 participants
OBSERVATIONAL
2011-06-30
2016-03-31
Brief Summary
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Detailed Description
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Subjects will return to the site six months and one year after completion of the Phase I study and then annually for a total study duration of four years. Phone calls will also be made by the Investigator to the subject's parent/legal guardian bi-annually to conduct a phone visit through the four-year duration of the study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HuCNS-SC transplanted subjects in the lead-in phase
Subjects who had HuCNS-SC transplant in the lead-in phase study CL-N01-PMD
HuCNS-SC transplant in the lead-in phase
Long-term safety follow-up study
Interventions
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HuCNS-SC transplant in the lead-in phase
Long-term safety follow-up study
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects who are concurrently enrolled in another investigational study.
MALE
No
Sponsors
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StemCells, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Huhn, MD
Role: STUDY_DIRECTOR
StemCells, Inc.
Locations
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UCSF Medical Center
San Francisco, California, United States
Countries
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Other Identifiers
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CL-N02-PMD
Identifier Type: -
Identifier Source: org_study_id
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