Stem cell shot aims to tame rheumatoid arthritis
NCT ID NCT04971980
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tests a single intravenous infusion of stem cells from donated umbilical cords (BC-U001) in 9 adults with moderate-to-severe rheumatoid arthritis who haven't responded well to standard treatments. The main goal is to check safety and find the right dose, while also looking for signs of reduced joint inflammation and disease activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord stem cells (BC-U001)
- What this could lead to
- If successful, this could point toward a new way to control rheumatoid arthritis with a single infusion, reducing inflammation and joint damage.
- What could go wrong
- This is a very early, small trial (9 people) focused on safety, not proof of effectiveness. The treatment may not work or could cause side effects.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2021
- Expected to finish
-
Nov 2025
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 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 or female patients aged 18 to 65 (inclusive) 2. Patients who are diagnosed with rheumatoid arthritis following the 2010 ACR/EULAR classification criteria 3. Patients who still remain moderate-to-high disease activity, i.e. DAS28\>3.2 at screening and study baseline, after standard csDMARDs therapy 4. Patients who are positive for rheumatoid factors (RF) and/or anti-CCP antibody 5. Patients who are clinically stable with no significant changes in physical condition from screening to study baseline 6. Patients who are available and willing to comply with all study procedures 7. 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 upper limits of normal 5. Creatinine clearance rate (Ccr) \< 45 ml/min calculated by Cockcroft-Gault formula 6. Severe 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 cerebrovascular accident (stroke) within 1 year before screening 9. Clinically significant heart disease (New York Heart Association, class III and class IV) 10. Surgery or trauma (e.g. contusions, abrasions, stab wounds, cutting wounds, crush injuries, impact injuries, and firearm injuries etc.) within 14 days before enrollment that are not approporiate to participate in study in investigators' opinion 11. 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 12. 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. 13. Known allergies or had a history of allergy to minor molecular heparinum and human serum albumin that are likely to interfere with patient compliance or study assessments/procedures in the investigators' opinion 14. Already participating in another interventional clinical trial or participated in another interventional clinical trial within 3 months before screening 15. Clinical history of malignancy with the exception of adequately treated cervical carcinoma in situ or basal cell carcinomas 16. Other situations that are not approporiate to participate in study in investigators' opinion
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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.
Contacts and locations
Locations
-
Peking Union Medical College Hospital (Dongdan campus)
Beijing, Beijing Municipality, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new injection calm rheumatoid arthritis? an early trial puts ZB002 to the test