Umbilical Cord Mesenchymal Stem Cell Secretome in Patients With Sjogren's Syndrome

Brief summary (registry, in English)

This randomized, placebo-controlled, double-blind trial evaluated the safety and efficacy of umbilical cord mesenchymal stem cell (UC-MSC) secretome, given as an add-on to standard therapy, in women with Sjogren's syndrome. Twenty-nine participants were randomly assigned to receive six intramuscular injections of either UC-MSC secretome or 0.9% sodium chloride (placebo) over five weeks, while continuing their usual corticosteroid and/or immunosuppressant treatment. The main outcome was the change in disease activity measured by the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI). Secondary outcomes were the inflammatory markers erythrocyte sedimentation rate (ESR) and high-sensitivity C-reactive protein (hs-CRP), and adverse events.

What you commit to

• Study type: Interventional · Phase 1/2
• Participants enrolled: 29
• From 1 May 2024 to the primary completion date, 1 Jun 2024
• 2 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.