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Cord blood stem cells could ease tough arthritis

NCT ID NCT03828344

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a single infusion of stem cells from donated umbilical cords in 16 adults with moderate to severe rheumatoid arthritis that hasn't improved with standard treatments. The main goal is to check safety and side effects over 52 weeks, while also looking for signs of symptom relief. It's a first step to see if this approach is safe enough for larger trials.

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

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 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

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 or female, aged 18 to 70, inclusive. 2. Have a diagnosis of RA in agreement with the 2010 ACR classification criteria: Sum of score equal or more than 6/10 in categories A-D including: A, Joint involvement; B, Serology; C, Acute-phase reactant; D, Duration of symptoms. 3. Have established RA \> 6 months of symptoms 4. Have had an inadequate response or documented intolerance to available RA therapies including csDMARDs and TNFi bDMARDs. 5. Current use of csDMARD treatment for RA with at least one of the following: methotrexate (up to 25 mg daily), sulfasalazine (up to 3 g daily), hydroxychloroquine (up to 400mg daily), or leflunomide (up to 20mg daily), or any combination of these agents (with the exception of methotrexate and leflunomide) for at least 3 months, with a stable dose (including route of administration for methotrexate) for at least 6 weeks prior to the screening visit (Visit 0) 6. Have SJC of 4 or more out of 28 at screening and baseline 7. Have TJC of 4 or more out of 28 at screening and baseline 8. CRP greater than upper limit of normal (ULN) 9. Positive for RF and/or anti-CCP antibodies but without extra-articular disease or functional limitations 10. Clinically stable with no significant changes in health status within 2 weeks prior to randomization 11. Stated willingness to comply with all study procedures and availability for the duration of the study 12. Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines. Exclusion Criteria: 1. Infections of hepatitis B, hepatitis C, active or latent tuberculosis, or positive for human immunodeficiency virus (HIV)1 or HIV2 2. Any history of ongoing, significant infections or recent serious infection, i.e., requiring hospitalization and or IV antimicrobial treatment in the 3 months prior to screening. 3. Any active inflammatory diseases other than RA. 4. Serum aminotransferase (ALT or AST) levels \> 2x ULN 5. Inadequate kidney function, defined as an estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73 m2 using Modification of Diet in Renal Disease (MDRD) 4-variable formula 6. Chronic obstructive pulmonary disease or known lung disease except for mild asthma treated with bronchodilators. 7. Any coexistent active major medical diagnosis of clinically significant cardiovascular, neurological psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or hematological abnormalities that are likely to interfere with patient compliance or study assessments/procedures in the investigators' opinion 8. History of transient ischemic attack 9. History of cerebrovascular accident (stroke) 10. Clinically significant heart disease (New York Heart Association, class III and class IV). 11. Surgery or trauma within 14 days. 12. Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study and for twelve months after completing the study infusion, unless surgically sterilized or postmenopausal during the study. 13. Washout period less than 6 months for rituximab or less than 4 weeks for other bDMARDs. 14. Corticosteroid usage at a high dose (i.e., IV or IM corticosteroids or use of oral prednisone equivalent \>10 mg/day) or not at a stable dose for the treatment of RA or other diseases within 28 days prior to randomization. 15. Known allergies or had a history of allergy to blood products 16. Blood product usage within 50 days (except albumin) 17. Already participating in another interventional clinical trial or participated in another interventional clinical trial within 3 months before screening. 18. Clinical history of malignancy with the exception of adequately treated cervical carcinoma in situ or basal cell carcinomas.

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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.

How to take part

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  1. The official record

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