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NCT05925647 Clinical Trial

The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05925647
Other study ID # NAP06
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 rheumatoid arthritis patients.

Description:

This research is experimental. The research subjects were 30 rheumatoid arthritis patients. The control group received a placebo, and the treatment group received mesenchymal stem cell secretome on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th. The data collected were erythroblastic acidity, hsCRP, interlukin 6, DAS-28, and assessment of drug side effects before and after therapy. 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 February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Rheumatoid Arthritis Patients Exclusion Criteria: - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Messenchymal stem cell 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 Rheumatoid Arthritis Disease Activity Disease Activity Score 28-joint count (DAS28) before and after therapy. The change of Disease activity score patients at 1 months
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