Could your own fat cells tame rheumatoid arthritis?
NCT ID NCT03691909
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a single infusion of stem cells taken from the patient's own belly fat in 15 adults with active rheumatoid arthritis. The main goal was to see if the treatment is safe over 12 months. Researchers also looked at whether it could lower inflammation markers like TNF-alpha and IL-6.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous adipose-derived mesenchymal stem cells (HB-adMSCs)
- What this could lead to
- If safe and effective, this could point toward a new way to control rheumatoid arthritis using a patient's own stem cells.
- What could go wrong
- This is an early, small safety trial with only 15 people, so it may not show clear benefit. Stem cell treatments also carry risks like infection or immune reactions.
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
-
15 people
The number who actually took part.
- Started
-
Sep 2018
- Finished
-
Sep 2020
- 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: * Adult male or female between the ages of 18 and 65 * Patients have active RA as confirmed by the following criteria: * ≥ 6 swollen joints and ≥ 6 tender joints at screening (68-joint count) * Abnormal CRP result OR abnormal ESR result at screening. Abnormal CRP result at screening OR abnormal ESR defined as: * CRP \> 4.9 mg/L or ESR \> 10mm/hr for men, \> 20mm/hr for women * Patients without current established treatment, or if being treated, patients who are on a stable dose of RA therapy regimen for ≥ 4 weeks prior to screening Exclusion Criteria: * Inability to understand and provide signed informed consent * Pregnancy, lactation, or, if female of childbearing potential, positive serum β-hCG at screening. * Currently diagnosed any malignant neoplasm. Any patient who was successfully treated for cancer and has been disease-free, with no recurrence, for at least 5 years, will be considered. * Uncontrolled systemic illness, including, but not limited to: hypertension (systolic \>150 mm Hg or diastolic \>95 mm Hg); diabetes; renal, hepatic, or cardiac failure or any laboratory abnormality that poses a safety risk to the subject such as: * Hemoglobin ≤8.5 g/dL * White blood cells (WBCs) ≤3,500/mm3 (3.5 G/L) * Any other illness which, in the opinion of the investigator, characterizes the subject as not being a good candidate for the study * Participation in another study with an investigational drug or device within 4 weeks prior to treatment or 5 half-lives of the investigational product used (whichever is longer). * Positive results of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV Ab), and/or human immunodeficiency virus antibody (HIV Ab) tests at screening (excluding patients who are tested positive for HBsAb alone due to a hepatitis B vaccination). * Positive history of Treponema pallidum.
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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
-
Accurate Clinical Research
Pasadena, Texas, 77034, United States
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