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UCB Transplant of Inherited Metabolic Diseases With Administration of Intrathecal UCB Derived Oligodendrocyte-Like Cells

Study acronym: DUOC-01
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Oct 2026 → Oct 2027
See other at-risk trials from Joanne Kurtzberg, MD

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 2026 to Oct 2027
    • Study description expanded, about 11 words
    v21
  2. Primary and study completion dates: Oct 2025 to Oct 2026
    • Site contact updated
    v20
  3. Primary and study completion dates: Oct 2024 to Oct 2025
    • Eligibility criteria revised
    • Site contact updated
    • Collaborators shortened, about 3 words
    v19
  4. Primary and study completion dates: Oct 2023 to Oct 2024
    • Eligibility criteria shortened, about 24 words
    • Study description expanded, about 14 words
    v18
  5. Enrollment target: 12 to 40
    • Primary and study completion dates: Sep 2022 to Oct 2023
    v17
Show 15 earlier versionsHide 15 earlier versions
  1. Site contact updatedv16
  2. 2 versions Re-verified since Dec 2, 2019, no change to tracked fieldsv14-v15
  3. Primary and study completion dates: Sep 2020 to Sep 2022v13
  4. Re-verified, no change to tracked fieldsv12
  5. Primary and study completion dates: Sep 2018 to Sep 2020v11
  6. Re-verified, no change to tracked fieldsv10
  7. Eligibility criteria expanded, about 5 wordsv9
  8. Primary and study completion dates: Sep 2017 to Sep 2018v8
  9. 5 versions Re-verified since Mar 16, 2015, no change to tracked fieldsv3-v7
  10. Lead sponsor: Duke University to Joanne Kurtzberg, MD
    • Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of the study is to determine the safety and feasibility of intrathecal administration of DUOC-01 in patients who are undergoing standard treatment with umbilical cord blood transplant (UCBT) for inborn errors of metabolism and who have evidence of early demyelinating disease in the central nervous system (CNS). The secondary objective of the study is to describe the efficacy of UCBT with intrathecal administration of DUOC-01 in these patients.
Trial Details
NCT Number NCT02254863
Lead Sponsor Joanne Kurtzberg, MD
Conditions
(from sponsor)		 Adrenoleukodystrophy, Batten Disease, Mucopolysaccharidosis II, Leukodystrophy, Globoid Cell, Leukodystrophy, Metachromatic, Neimann Pick Disease, Pelizaeus-Merzbacher Disease, Sandhoff Disease +4 more
Related terms Adrenoleukodystrophy, alpha-Mannosidosis, Brain Diseases, Metabolic, Inborn, Leukodystrophy, Globoid Cell, Leukodystrophy, Metachromatic, Mucopolysaccharidosis II, Neuronal Ceroid-Lipofuscinoses, Niemann-Pick Disease, Type A, Pelizaeus-Merzbacher Disease, Sandhoff Disease, Tay-Sachs Disease
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov