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NCT05921058 Clinical Trial

The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

Lupus Erythematosus Clinical Trial

Official title:
The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05921058
Other study ID # NAP05
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2022
Est. completion date March 9, 2023

Study information
Verified date June 2023
Source Universitas Sebelas Maret
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date March 9, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Lupus paatients Exclusion Criteria: - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Secretome
Mesenchymal stem cell secretome obtained from Kalbe Pharma Company
• Placebo
NaCl 0,9% infusion

Locations
Country Name City State
Indonesia Moewardi General Hospital Surakarta Middle Java

Sponsors (1)
Lead Sponsor Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021. — View Citation

Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Lupus Disease activity The data collected were MEX SLEDAI score (range 0-32) before and after therapy. Change of Lupus Disease Activity at 1 months
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