The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

Universitas Sebelas Maret

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lupus Erythematosus

Treatments: Drug: Secretome; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05921058

NAP05

Details and patient eligibility

About

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

Full 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

Enrollment: 15 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Lupus paatients

Exclusion criteria

• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

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: Secretome

Placebo

Placebo Comparator group

Description:

Nacl 0,9% infusion

Treatment:

Drug: Placebo