Cord blood cells injected into spine show promise for MS
NCT ID NCT04943289
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a new cell therapy called DUOC-01, made from donated umbilical cord blood, in 20 adults with primary progressive multiple sclerosis (PPMS). The cells were injected into the spinal fluid to see if it was safe. Researchers also looked for early signs of benefit on brain scans and disability scores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DUOC-01 (cells from donated umbilical cord blood)
- What this could lead to
- If safe, this could pave the way for a new treatment that slows or repairs nerve damage in progressive MS.
- What could go wrong
- This is a very early, small safety trial with only 20 people. It is not designed to prove effectiveness, and side effects from the injection or cells are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Jan 2021
- Finished
-
Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female subjects must be 18-65 years of age 2. Diagnosis of primary progressive MS according to 2017 revised McDonald criteria (26) 3. EDSS score at screening 3.0-6.5 that was not acquired within the last 6 months 4. Stable disease state as evidenced by no significant change in EDSS (1 point or more) in the last 3 months 5. Patients must have a suitably matched, banked UCB per section 5.3 6. Able to complete a written informed consent prior to any study assessments 7. 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. 8. Patient is a good candidate for the trial, in the opinion of the Investigators 9. Subjects on disease-modifying therapies upon entering the study must continue on these therapies as a concomitant treatment throughout the course of the study to minimize additional variables. However, changes in these disease-modifying therapies can occur at the clinician's discretion, if there are clinical reasons to do so, which would be documented. Exclusion Criteria: * 1\. Prior organ, tissue, or stem cell transplant or cell therapy within 3 years of study entry 2. Diagnosis of a progressive neurological disorder other than MS 3. Active, chronic disease of the immune system other than MS 4. Any medical condition that the investigator deems as unsuitable with therapy 5. Inability to have an MRI brain scan, or lumbar puncture (i.e., claustrophobia, allergy to contrast, bleeding disorder, or on anticoagulation) 6. Intractable seizures 7. Chronic aspiration 8. Bleeding disorder 9. Evidence of HIV infection or HIV positive serology 10. Uncontrolled bacterial, viral, or fungal infection within 2 weeks of DUOC-01 administration, as defined by progression while on appropriate treatment 11. History of malignancy of any organ system within the past two years with the exception of basal cell carcinoma or squamous cell carcinoma of the skin that has been excised with clear margins. 12. Requirement of ventilatory support 13. Pregnant or breastfeeding or intention to become pregnant during the study 14. Active concurrent malignancy, or receiving concurrent radiotherapy, immunosuppressive medications for conditions other than MS, or cytotoxic chemotherapy 15. Patients with Suicidal Ideation in the past 6 months per screening on C-SSRS; patients with Suicidal Behavior in the past 2 years, except for Non-suicidal self-injurious behavior 16. Abnormal lab values: * Total bilirubin\>2.0 mg/dl unless due to Gilbert's syndrome * AST or ALT \> 5 times the ULN * WBC \<2.0x 103/μL * ALC \<0.5 x 103/ μL * Serum creatinine \>2x ULN * eGFR \<60 mg/mmol * CD4 count \<200 cells/mm3
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Primary progressive multiple sclerosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Duke University Medical Center
Durham, North Carolina, 27705, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One-Time CAR-T infusion tested against progressive MS
- Can engineered immune cells tame autoimmune diseases?
- Can a blood pressure pill slow MS disability?
- Could a simple injection replace an IV for MS treatment?
- Could a common supplement fight fatigue in progressive MS?
- Tears may replace spinal taps for MS diagnosis