Lupus Erythematosus
Conditions
Keywords
Messenchymal Stem Cell Secretome, Lupus
Brief summary
This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.
Detailed description
This research is experimental. The study was conducted on 30 SLE patient subjects. the treatment group who got the mesenchymal stem cell secretome on the 1st, 2nd day, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th days. ESR, hs-CRP, C3, C4, interlukin 6, anti-ds-DNA antibody, MEX SLEDAI score, and assessment of drug side effects before and after therapy were collected. Statistical test with paired difference test with p \< 0.05
Interventions
DRUGSecretome
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
* Lupus paatients
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lupus Disease activity | Change of Lupus Disease Activity at 1 months | The data collected were MEX SLEDAI score (range 0-32) before and after therapy. |
Countries
Indonesia
Outcome results
None listed