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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
Must not have
Intractable seizures
Active, chronic disease of the immune system other than MS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post infusion
Awards & highlights
Summary
This trial tests the safety of injecting special cells from umbilical cord blood into the spinal fluid of adults with a severe form of multiple sclerosis. The goal is to see if these cells can help repair nerve damage and reduce inflammation. About 20 participants will be monitored over time to check for any improvements and side effects. Umbilical cord blood cells have been studied for their potential to treat neurological disorders, including spinal cord injuries, due to their ability to produce neurotrophic factors and modulate immune responses.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have seizures that medication cannot control.
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I have a chronic immune system disease other than MS.
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I am not currently receiving treatment for another cancer, nor am I on immunosuppressants for conditions other than MS or undergoing cytotoxic chemotherapy.
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I have not had an organ, tissue, or stem cell transplant or cell therapy in the last 3 years.
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I need help with breathing (ventilator support).
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I have a bleeding disorder.
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I have a progressive neurological disorder that is not MS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of IT administration adverse events
Incidence of adverse events attributed to the investigational product
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) and cell-based therapies. DMTs, such as interferons and monoclonal antibodies, work by modulating the immune system to reduce inflammation and prevent immune cells from attacking the myelin sheath, which is crucial for protecting nerve fibers.
Cell-based therapies, like the DUOC-01 cells derived from human umbilical cord blood, aim to repair and regenerate damaged tissues by promoting remyelination and providing neuroprotection. These mechanisms are vital for MS patients as they help slow disease progression, reduce relapse rates, and improve overall neurological function, thereby enhancing the quality of life.
Proteome analysis of post-transplantation recovery mechanisms of an EAE model of multiple sclerosis treated with embryonic stem cell-derived neural precursors.Disease-modifying treatments for progressive multiple sclerosis.Spotlight on anti-CD20.
Proteome analysis of post-transplantation recovery mechanisms of an EAE model of multiple sclerosis treated with embryonic stem cell-derived neural precursors.Disease-modifying treatments for progressive multiple sclerosis.Spotlight on anti-CD20.
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Who is running the clinical trial?
Joanne Kurtzberg, MDLead Sponsor
18 Previous Clinical Trials
693 Total Patients Enrolled
Beth Shaz, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a severe infection in the last 2 weeks.I have seizures that medication cannot control.I have a chronic immune system disease other than MS.I am not currently receiving treatment for another cancer, nor am I on immunosuppressants for conditions other than MS or undergoing cytotoxic chemotherapy.My disability score is between 3.0 and 6.5, and it has been stable for the last 6 months.I have not had an organ, tissue, or stem cell transplant or cell therapy in the last 3 years.I need help with breathing (ventilator support).I have a bleeding disorder.I haven't had cancer in the last 2 years, except for certain skin cancers that were fully removed.I have been diagnosed with primary progressive MS.I have a progressive neurological disorder that is not MS.I have a matching umbilical cord blood unit stored.I will continue my current disease treatments while participating in the study.I am between 18 and 65 years old.My condition has not worsened in the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: DUOC-01
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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