The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients

Universitas Sebelas Maret

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Messenchymal stem cell secretome; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05925647

NAP06

Details and patient eligibility

About

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

Full 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

Enrollment: 15 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rheumatoid Arthritis Patients

Exclusion criteria

• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Messenchymal stem cell secretome

Experimental group

Description:

The hypoxic mesenchymal stem cell secretome has been developed up to chapter 7, stored at -196 C to -135 C in cryopreservation, and has passed quality tests.

Treatment:

Drug: Messenchymal stem cell secretome

Placebo

Placebo Comparator group

Description:

Nacl 0,9% infusion

Treatment:

Drug: Placebo