Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Messenchymal stem cell secretome
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
Interventions
DRUGMessenchymal stem cell secretome
Mesenchymal stem cell secretome obtained from Kalbe Pharma Company
DRUGPlacebo
NaCl 0,9% infusion
Sponsors
Universitas Sebelas Maret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Mesenchymal stem cell placebo and secretome using injections that are similar in shape and color
Intervention model description
This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Rheumatoid Arthritis Patients
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Indonesia
Outcome results
None listed