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Recruiting NCT07439848

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

Phase I / Phase II Interventional Acute Respiratory Distress Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control (NaCl 0.9%), UC-MSC, UC-MSC and Secretome.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Detailed description

This study is conducted to determine the effect of adjuvant treatment in severe ARDS patients by comparing the Injury score (pre and post), which includes: chest radiograph examination results, hypoxemia score, PEEP score, and respiratory system compliance score. In addition, the results will be calculated and summed to see if it can be defined as subjects with no lung injury (cured), mild-moderate, and severe. Data is also assessed based on laboratory results from complete blood count, D-dimer, Procalcitonin, CRP and inflammatory factors IL6, IL12, and TNF-a. 2 mL of Secretome are given on days 1, 4, and 7, and MSC as much as 1 x 106/kg, Intravenous, on days 2, 5, and 8. This method is a controlled experimental comparative study, in which the researcher provides two or more interventions to the patients used for the sample, which will then be tested for the success and effectiveness of treatment in the three groups.

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.

Primary outcome measures

  • Lung Injury Score [Time frame: Before therapy]
  • Lung Injury Score [Time frame: days 3]
  • Lung Injury Score [Time frame: days 6]
  • Lung Injury Score [Time frame: days 13]
  • Lung Injury Score [Time frame: days 14]
  • Lung Injury Score [Time frame: days 28]
  • Sequential organ Failure Assessment Score (SOFA) [Time frame: Before therapy]
  • Sequential organ Failure Assessment Score (SOFA) [Time frame: days 3]
  • Sequential organ Failure Assessment Score (SOFA) [Time frame: days 6]
  • Sequential organ Failure Assessment Score (SOFA) [Time frame: days 13]

Eligibility criteria

Inclusion criteria

  • Male or female at least 40 years old when the Informed Consent Form (ICF) is signed by the family, as evidenced by an identity card.
  • Patients with severe ARDS according to Berlin criteria
  • Families are willing to participate in clinical trial procedures including not participating in other clinical trials for the duration of participation.

Exclusion criteria

  • A pregnant woman is proven by a pregnancy test.
  • The results of the SGOT or SGPT examination increased > 5 times the upper limit of the normal laboratory value in the hospital.
  • Estimated glomerular filtration rate (eGFR) < 30 ml/min, including patients undergoing routine hemodialysis.
  • Having more than 2 of the following co-morbidities; hypertension, diabetes, chronic heart disease, chronic lung disease, COPD, asthma, tuberculosis, cancer, chronic kidney disease, immunosuppressive disease, HIV.
  • The results of the lipid profile are far above normal (what is the cut off number?). Normal cholesterol levels for women aged 20 years and over are 125-200 mg/dL with LDL below 100 mg/dL and HDL above 40 mg/dL. It is said to have high cholesterol when the level in the blood reaches more than 239 mg/dL. Normal cholesterol levels for men aged 20 years or older are 125-200 mg/dL with LDL below 100 mg/dL and HDL above 40 mg/dL. It is said to have high cholesterol when the level in the blood reaches more than 239 mg/dL.
  • PT APTT, C Peptide

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • RSPAD Gatot Soebroto — Jakarta Pusat

Identifiers

NCT: NCT07439848 · CT/SPS/05/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗