The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients
Phase 1
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: PlaceboDrug: Messenchymal stem cell secretome
- Registration Number
- NCT05925647
- Lead Sponsor
- Universitas Sebelas Maret
- Brief Summary
This research is a clinical trial of administering mesenchymal stem cell secretome to rheumatoid arthritis patients.
- Detailed Description
This research is experimental. The research subjects were 30 rheumatoid arthritis patients. The control group received a placebo, and the treatment group received mesenchymal stem cell secretome on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th. The data collected were erythroblastic acidity, hsCRP, interlukin 6, DAS-28, and assessment of drug side effects before and after therapy. Statistical test with paired difference test with p\<0.05
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Rheumatoid Arthritis Patients
Exclusion Criteria
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Nacl 0,9% infusion Messenchymal stem cell secretome Messenchymal stem cell secretome The hypoxic mesenchymal stem cell secretome has been developed up to chapter 7, stored at -196 C to -135 C in cryopreservation, and has passed quality tests.
- Primary Outcome Measures
Name Time Method Rheumatoid Arthritis Disease Activity The change of Disease activity score patients at 1 months Disease Activity Score 28-joint count (DAS28) before and after therapy.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Moewardi General Hospital
🇮🇩Surakarta, Middle Java, Indonesia