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Stem Cell Therapy

DUOC-01 for Multiple Sclerosis (DUOC for MS Trial)

Phase 1
Recruiting
Led By Beth Shaz, MD
Research Sponsored by Joanne Kurtzberg, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
EDSS score at screening 3.0-6.5 that was not acquired within the last 6 months
Diagnosis of primary progressive MS according to 2017 revised McDonald criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post infusion
Awards & highlights

DUOC for MS Trial Summary

This trial will assess the safety of using DUOC-01 cells, expanded from donated human umbilical cord blood, to treat adults with Primary Progressive Multiple Sclerosis. There will be 20 participants enrolled and researchers will explore changes in MS assessment scores, brain MRI findings, and blood biomarkers.

Who is the study for?
Adults aged 18-65 with Primary Progressive Multiple Sclerosis (PPMS) and an EDSS score of 3.0-6.5 are eligible for this trial. Participants must have stable MS, a matched umbilical cord blood unit available, and agree to effective contraception during the study plus six months after treatment. Exclusions include prior transplants or cell therapies within three years, other progressive neurological disorders, recent malignancies except certain skin cancers, active immune diseases besides MS, MRI or lumbar puncture contraindications, severe infections, ventilatory support need, recent suicidal behavior or ideation.Check my eligibility
What is being tested?
The trial is testing DUOC-01 cells administered intrathecally (into the spinal canal) to treat PPMS. DUOC-01 is derived from human umbilical cord blood cells aimed at treating neurodegenerative conditions. This Phase 1a open-label single-center study will enroll about 20 participants and explore changes in MS scores, brain MRI results, and blood biomarkers.See study design
What are the potential side effects?
As this is a Phase 1a safety trial for DUOC-01 cells in PPMS patients; specific side effects are not listed but may include typical risks associated with intrathecal procedures such as headache or back pain and potential immune reactions due to stem cell therapy.

DUOC for MS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disability score is between 3.0 and 6.5, and it has been stable for the last 6 months.
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I have been diagnosed with primary progressive MS.
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I have a matching umbilical cord blood unit stored.
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I will continue my current disease treatments while participating in the study.
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I am between 18 and 65 years old.
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My condition has not worsened in the past 3 months.

DUOC for MS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of IT administration adverse events
Incidence of adverse events attributed to the investigational product

DUOC for MS Trial Design

1Treatment groups
Experimental Treatment
Group I: DUOC-01Experimental Treatment1 Intervention
Intrathecal Infusion of DUOC-01 and hydrocortisone. Cohort 1: 10 million cells Cohort 2: greater than 10 to 25 million cells Cohort 3: greater than 25 to 50 million cells

Find a Location

Who is running the clinical trial?

Joanne Kurtzberg, MDLead Sponsor
18 Previous Clinical Trials
696 Total Patients Enrolled
Beth Shaz, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
137 Total Patients Enrolled

Media Library

DUOC-01 (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04943289 — Phase 1
Multiple Sclerosis Research Study Groups: DUOC-01
Multiple Sclerosis Clinical Trial 2023: DUOC-01 Highlights & Side Effects. Trial Name: NCT04943289 — Phase 1
DUOC-01 (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04943289 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation accepted in this research protocol?

"This research is open to anyone who is 18 years of age or older, and not yet 65."

Answered by AI

Is DUOC-01 a risk-free option for individuals?

"Due to the limited data available on DUOC-01, Power has assigned a score of 1 to its safety rating. Phase 1 trials provide only preliminary support for both efficacy and safety."

Answered by AI

Is recruitment currently open for this clinical trial?

"Correct. Clinicaltrials.gov indicates that this medical trial is currently recruiting participants; the initial post was published on January 24th 2021, and it has since been updated as recently as January 25th 2022. The study requires 20 patients to be enrolled at one site."

Answered by AI

Does my profile qualify me to participate in this research?

"The qualifications for this clinical trial involve being between 18 and 65 years old, having primary progressive multiple sclerosis, and with a total of 20 participants accepted."

Answered by AI

How many participants is this research project accommodating?

"Affirmative. As per the information held on clinicaltrials.gov, this medical experiment is currently open for recruitment which commenced on January 24th 2021 and was last updated a year later. 20 participants are required from one single location."

Answered by AI
Recent research and studies
~6 spots leftby Aug 2025