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NCT04943289 · ClinicalTrials.gov registry record · Phase 1

Intrathecal Administration of DUOC-01 in Adults With Primary Progressive Multiple Sclerosis

A Phase 1 study, sponsored by Joanne Kurtzberg, MD.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT04943289: Completed Phase 1 study, sponsored by Joanne Kurtzberg, MD.

NCT04943289 is a Phase 1 study that has completed, run by Joanne Kurtzberg, MD. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04943289, a Phase 1 study, has completed, sponsored by Joanne Kurtzberg, MD.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

This study is a prospective Phase 1a open-label single- center trial. It will assess the safety of intrathecal administration of DUOC-01 cells to adults with Primary Progressive Multiple Sclerosis (PPMS). DUOC-01 is a population of cells expanded from donated human umbilical cord blood cells and is intended for treatment of neurodegenerative and demyelinating diseases. There will be approximately 20 participants enrolled. Exploratory objectives include changes in MS assessment scores, changes in brain MRI findings, and changes in blood biomarkers.

Primary Outcome

Total number of adverse events associated with DUOC-01 infusion

Interventions

  • BIOLOGICAL DUOC-01

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-01-24
Est. Completion 2025-09-30
Phase Phase 1
Joanne Kurtzberg, MD

15 total trials

What the finished NCT04943289 record still lists

NCT04943289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which DUOC-01 is the first listed.

NCT04943289 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04943289 about?

NCT04943289 is a clinical study titled "Intrathecal Administration of DUOC-01 in Adults With Primary Progressive Multiple Sclerosis". This study is a prospective Phase 1a open-label single- center trial. It will assess the safety of intrathecal administration of DUOC-01 cells to adults with Primary Progressive Multiple Sclerosis (PPMS). DUOC-01 is a population of cells expanded from donated human umbilical cord blood cells and is ...

What is the current status of trial NCT04943289?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-01-24. Estimated completion is 2025-09-30.

What interventions are being tested in trial NCT04943289?

The interventions under investigation include: DUOC-01 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04943289?

This trial is sponsored by Joanne Kurtzberg, MD, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04943289's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04943289, the US trial registry maintained by the National Library of Medicine. NCT04943289 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.