The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.

Completed

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Key information

Conditions

Lupus Erythematosus

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Moewardi General Hospital

Surakarta, Middle Java, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Lupus paatients

Exclusion criteria

Pregnancy

Treatment and study plan

Secretome

Drug

Mesenchymal stem cell secretome obtained from Kalbe Pharma Company

Other names: Messenchymal stem cell Concitioned Media

Placebo

Drug

NaCl 0,9% infusion

Other names: NaCl 0,9% infusion

Primary outcomes

Lupus Disease activity

Time frame: Change of Lupus Disease Activity at 1 months

The data collected were MEX SLEDAI score (range 0-32) before and after therapy.

Sponsors and collaborators

Lead sponsor

Universitas Sebelas Maret

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Jun 27, 2023
Registry last updated: Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed