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RECRUITING
NCT07439848
PHASE1/PHASE2

Mesenchymal Stem Cells (MSCs) and Conditioned Medium Mesenchymal Stem Cells as Adjuvant Therapy for Sepsis

Sponsor: PT. Prodia Stem Cell Indonesia

View on ClinicalTrials.gov

Summary

This study was conducted to determine the effect of Umbilical Cord Mesenchymal Stem Cell (UC-MSC) and Secretome in severe ARDS patients. The study is a randomized control trial - double blind, which has 3 arms intervention namely, Control treatment, UC-MSC treatment, and UC-MSC and Secretome treatment.

Official title: A Randomized, Double-Blind, Controlled Trial Evaluating the Potential of Mesenchymal Stem Cells and Their Secretome as Adjuvant Therapy to Reduce Length of Hospital Stay and Mortality in Patients With Sepsis Due to Pneumonia

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-12-25

Completion Date

2026-12

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

OTHER

Control (NaCl 0.9%)

Standard of Care (SoC) + IV placebo (NaCl 0.9%) on the 2nd, 5th, 8th day + nasal drop 2 mL (growth medium) on the 1st, 4th, 7th day.

BIOLOGICAL

UC-MSC

Standard of Care (SoC) + IV 10 million kg/body weight UC-MSC on the 2nd, 5th, 8th day + nasal drop 2 mL (growth medium) on the 1st, 4th, 7th day.

BIOLOGICAL

UC-MSC and Secretome

Standard of Care (SoC) + IV 10 million kg/body weight UC-MSC on the 2nd, 5th, 8th day + nasal drop 2 mL of Secretome on the 1st, 4th, 7th day.

Locations (1)

RSPAD Gatot Soebroto

Jakarta Pusat, DKI Jakarta, Indonesia