NCT05921058

The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Universitas Sebelas Maret · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Secretome	Mesenchymal stem cell secretome obtained from Kalbe Pharma Company
DRUG	Placebo	NaCl 0,9% infusion

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-12-30
• Completion: 2023-03-09
• First posted: 2023-06-27
• Last updated: 2023-06-27

Locations

1 site across 1 country: Indonesia