The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients

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

Completed

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

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 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Rheumatoid Arthritis Patients

Exclusion criteria

Pregnancy

Treatment and study plan

Messenchymal stem cell 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

Rheumatoid Arthritis Disease Activity

Time frame: The change of Disease activity score patients at 1 months

Disease Activity Score 28-joint count (DAS28) before and after therapy.

Sponsors and collaborators

Lead sponsor

Universitas Sebelas Maret

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jun 29, 2023
Registry last updated: Jun 29, 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.

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Completed