CompletedPhase 1

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

United States20 participantsStarted 2021-01-24

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male and female subjects must be 18-65 years of age
✓. Diagnosis of primary progressive MS according to 2017 revised McDonald criteria (26)
✓. EDSS score at screening 3.0-6.5 that was not acquired within the last 6 months
✓. Stable disease state as evidenced by no significant change in EDSS (1 point or more) in the last 3 months
✓. Patients must have a suitably matched, banked UCB per section 5.3
✓. Able to complete a written informed consent prior to any study assessments
✓. Patients of childbearing potential must practice effective contraception during the study, and be willing to continue contraception for at least 6 months after DUOC-01 dosing so that, in the opinion of the Investigator, they will not become pregnant during the course of the study.
✓. Patient is a good candidate for the trial, in the opinion of the Investigators

What they're measuring

Incidence of IT administration adverse events

Timeframe: 2 weeks post infusion

Incidence of adverse events attributed to the investigational product

Timeframe: 1 year post infusion

Trial details

NCT IDNCT04943289

SponsorJoanne Kurtzberg, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

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