The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

Universitas Sebelas Maret15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lupus Erythematosus

Interventions

SecretomeDRUG

Mesenchymal stem cell secretome obtained from Kalbe Pharma Company

PlaceboDRUG

NaCl 0,9% infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Lupus paatients Exclusion Criteria: * Pregnancy

Locations (1)

Moewardi General Hospital

Surakarta, Middle Java, Indonesia

Outcomes

Primary Outcomes

Lupus Disease activity

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

Time frame: Change of Lupus Disease Activity at 1 months

Data from ClinicalTrials.gov

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