Actively Recruiting

Phase 1
Phase 2
Age: 40Years +
All Genders
NCT07439848

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

Led by PT. Prodia Stem Cell Indonesia · Updated on 2026-02-27

15

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

Sponsors

P

PT. Prodia Stem Cell Indonesia

Lead Sponsor

R

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female at least 40 years old when the Informed Consent Form is signed by the family
  • Patients with severe Acute Respiratory Distress Syndrome (ARDS) according to Berlin criteria
  • Families willing to participate in clinical trial procedures and not join other clinical trials during participation
Not Eligible

You will not qualify if you...

  • Pregnant women confirmed by pregnancy test
  • Liver enzyme (SGOT or SGPT) levels more than 5 times the normal upper limit
  • Estimated glomerular filtration rate (eGFR) less than 30 ml/min or patients on routine hemodialysis
  • Having more than two of these co-morbidities: hypertension, diabetes, chronic heart disease, chronic lung disease, COPD, asthma, tuberculosis, cancer, chronic kidney disease, immunosuppressive disease, HIV
  • Blood lipid profile far above normal levels (cholesterol above 239 mg/dL)
  • Abnormal PT APTT or C Peptide test results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

RSPAD Gatot Soebroto

Jakarta Pusat, DKI Jakarta, Indonesia, 10410

Actively Recruiting

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Research Team

D

Dewiyana Andari Kusmana

CONTACT

C

Cynthia R Retna Sartika, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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