The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

Phase 1

Completed

• Conditions: Lupus Erythematosus
• Interventions: Drug: Secretome; Drug: Placebo

• Registration Number: NCT05921058
• Lead Sponsor: Universitas Sebelas Maret

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

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-12-30
• Study Completion: 2023-03-09
• Study First Submitted: 2023-03-09
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-25
• Last Update Submitted: 2023-06-25
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Lupus paatients

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Messenchymal stem cell secretome	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.
Placebo	Placebo	Nacl 0,9% infusion

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Moewardi General Hospital; 🇮🇩 Surakarta, Middle Java, Indonesia