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NCT Number: NCT07439848

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

RSPAD Gatot Soebroto

Jakarta Pusat, DKI Jakarta, 10410, Indonesia

Location status: Recruiting

Location contact

dr. Dewiyana Andari Kusmana, SpP

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control (NaCl 0.9%)

Other

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.

Other names: Standard of Care (SoC)

UC-MSC

Biological

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.

Other names: Umbilical Cord- Mesenchymal Stem Cell (UC-MSC)

UC-MSC and Secretome

Biological

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.

Other names: Umbilical Cord- Mesenchymal Stem Cell (UC-MSCS) and Secretome

Primary outcomes

  1. Lung Injury Score

    Time frame: Before therapy

    Lung injury score is a method to assess the severity of acute lung injury. Assessment includes chest radiograph, hypoxaemia score, PEEP score, and respiratory system compliance score.

  2. Lung Injury Score

    Time frame: days 3

    Lung injury score is a method to assess the severity of acute lung injury. Assessment includes chest radiograph, hypoxaemia score, PEEP score, and respiratory system compliance score.

  3. Lung Injury Score

    Time frame: days 6

    Lung injury score is a method to assess the severity of acute lung injury. Assessment includes chest radiograph, hypoxaemia score, PEEP score, and respiratory system compliance score.

  4. Lung Injury Score

    Time frame: days 13

    Lung injury score is a method to assess the severity of acute lung injury. Assessment includes chest radiograph, hypoxaemia score, PEEP score, and respiratory system compliance score.

  5. Lung Injury Score

    Time frame: days 14

    Lung injury score is a method to assess the severity of acute lung injury. Assessment includes chest radiograph, hypoxaemia score, PEEP score, and respiratory system compliance score.

  6. Lung Injury Score

    Time frame: days 28

    Lung injury score is a method to assess the severity of acute lung injury. Assessment includes chest radiograph, hypoxaemia score, PEEP score, and respiratory system compliance score.

  7. Sequential organ Failure Assessment Score (SOFA)

    Time frame: Before therapy

    SOFA is a score for predicting ICU death based on lab results and clinical data. Scores assessment includes Partial pressure of oxygen (PaO2), Fraction of inspired oxygen (FiO2), use of mechanical ventilators, erythrocyte sedimentation rate (ESR), Glagow Coma Skill (GCS), Bilirubin, Mean arterial pressure (MAP) or vasoactive administration, and creatinine.

  8. Sequential organ Failure Assessment Score (SOFA)

    Time frame: days 3

    SOFA is a score for predicting ICU death based on lab results and clinical data. Scores assessment includes Partial pressure of oxygen (PaO2), Fraction of inspired oxygen (FiO2), use of mechanical ventilators, erythrocyte sedimentation rate (ESR), Glagow Coma Skill (GCS), Bilirubin, Mean arterial pressure (MAP) or vasoactive administration, and creatinine.

  9. Sequential organ Failure Assessment Score (SOFA)

    Time frame: days 6

    SOFA is a score for predicting ICU death based on lab results and clinical data. Scores assessment includes Partial pressure of oxygen (PaO2), Fraction of inspired oxygen (FiO2), use of mechanical ventilators, erythrocyte sedimentation rate (ESR), Glagow Coma Skill (GCS), Bilirubin, Mean arterial pressure (MAP) or vasoactive administration, and creatinine.

  10. Sequential organ Failure Assessment Score (SOFA)

    Time frame: days 13

    SOFA is a score for predicting ICU death based on lab results and clinical data. Scores assessment includes Partial pressure of oxygen (PaO2), Fraction of inspired oxygen (FiO2), use of mechanical ventilators, erythrocyte sedimentation rate (ESR), Glagow Coma Skill (GCS), Bilirubin, Mean arterial pressure (MAP) or vasoactive administration, and creatinine.

  11. Sequential organ Failure Assessment Score (SOFA)

    Time frame: days 14

    SOFA is a score for predicting ICU death based on lab results and clinical data. Scores assessment includes Partial pressure of oxygen (PaO2), Fraction of inspired oxygen (FiO2), use of mechanical ventilators, erythrocyte sedimentation rate (ESR), Glagow Coma Skill (GCS), Bilirubin, Mean arterial pressure (MAP) or vasoactive administration, and creatinine.

  12. Sequential organ Failure Assessment Score (SOFA)

    Time frame: days 28

    SOFA is a score for predicting ICU death based on lab results and clinical data. Scores assessment includes Partial pressure of oxygen (PaO2), Fraction of inspired oxygen (FiO2), use of mechanical ventilators, erythrocyte sedimentation rate (ESR), Glagow Coma Skill (GCS), Bilirubin, Mean arterial pressure (MAP) or vasoactive administration, and creatinine.

  13. Acute Physiology and Chronic Health Evaluation Score (APACHE)

    Time frame: Before therapy

    Apache is a score to estimate death in the ICU based on a history of organ failure or immunocompromise, age, body temperature, MAP, pH, heart rate, respiratory rate, sodium, potassium, creatinine, acute kidney failure, hematocrit, leukocyte cell count, GCS, FiO2.

  14. Acute Physiology and Chronic Health Evaluation Score (APACHE)

    Time frame: days 3

    Apache is a score to estimate death in the ICU based on a history of organ failure or immunocompromise, age, body temperature, MAP, pH, heart rate, respiratory rate, sodium, potassium, creatinine, acute kidney failure, hematocrit, leukocyte cell count, GCS, FiO2.

  15. Acute Physiology and Chronic Health Evaluation Score (APACHE)

    Time frame: days 6

    Apache is a score to estimate death in the ICU based on a history of organ failure or immunocompromise, age, body temperature, MAP, pH, heart rate, respiratory rate, sodium, potassium, creatinine, acute kidney failure, hematocrit, leukocyte cell count, GCS, FiO2.

  16. Acute Physiology and Chronic Health Evaluation Score (APACHE)

    Time frame: days 13

    Apache is a score to estimate death in the ICU based on a history of organ failure or immunocompromise, age, body temperature, MAP, pH, heart rate, respiratory rate, sodium, potassium, creatinine, acute kidney failure, hematocrit, leukocyte cell count, GCS, FiO2.

  17. Acute Physiology and Chronic Health Evaluation Score (APACHE)

    Time frame: days 14

    Apache is a score to estimate death in the ICU based on a history of organ failure or immunocompromise, age, body temperature, MAP, pH, heart rate, respiratory rate, sodium, potassium, creatinine, acute kidney failure, hematocrit, leukocyte cell count, GCS, FiO2.

  18. Acute Physiology and Chronic Health Evaluation Score (APACHE)

    Time frame: days 28

    Apache is a score to estimate death in the ICU based on a history of organ failure or immunocompromise, age, body temperature, MAP, pH, heart rate, respiratory rate, sodium, potassium, creatinine, acute kidney failure, hematocrit, leukocyte cell count, GCS, FiO2.

  19. Laboratorium (IL-6 IL-12)

    Time frame: Before therapy

    IL-6 is a pro-inflammatory cytokine that increases when ARDS occurs in the blood.

    • IL-12 is a cytokine that is produced by myeloid and other cell types.

  20. Laboratorium (IL-6 IL-12)

    Time frame: days 6

    IL-6 is a pro-inflammatory cytokine that increases when ARDS occurs in the blood.

    • IL-12 is a cytokine that is produced by myeloid and other cell types.

  21. Laboratorium (IL-6 IL-12)

    Time frame: days 13

    IL-6 is a pro-inflammatory cytokine that increases when ARDS occurs in the blood.

    • IL-12 is a cytokine that is produced by myeloid and other cell types.

  22. Laboratorium (Whole blood, TNF-α, Procalcitonin, D-dimer, SGOT, SGPT

    Time frame: Before therapy

    Whole blood check includes of hemoglobin (Hb), hematocrit (Ht), erythrocytes, leukocytes, platelets, type count (basophiles, eosinophils, lymphocytes, monocytes), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration ( MCHC), and red cell distribution width (RDW).

    • Tumor necrosis factor (TNF-α) is a proinflammatory factor that increases during ARDS.
    • Procalcitonin (PCT) is a peptide precursor of the hormone calcitonin, the latter being involved with calcium homeostasis.
    • D-dimer is a protein fragment that is released when a blood clot breaks down.
    • Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) are an enzyme produced by the liver.

  23. Laboratorium (Whole blood, TNF-α, Procalcitonin, D-dimer, SGOT, SGPT

    Time frame: days 3

    Whole blood check includes of hemoglobin (Hb), hematocrit (Ht), erythrocytes, leukocytes, platelets, type count (basophiles, eosinophils, lymphocytes, monocytes), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration ( MCHC), and red cell distribution width (RDW).

    • Tumor necrosis factor (TNF-α) is a proinflammatory factor that increases during ARDS.
    • Procalcitonin (PCT) is a peptide precursor of the hormone calcitonin, the latter being involved with calcium homeostasis.
    • D-dimer is a protein fragment that is released when a blood clot breaks down.
    • Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) are an enzyme produced by the liver.

  24. Laboratorium (Whole blood, TNF-α, Procalcitonin, D-dimer, SGOT, SGPT

    Time frame: days 6

    Whole blood check includes of hemoglobin (Hb), hematocrit (Ht), erythrocytes, leukocytes, platelets, type count (basophiles, eosinophils, lymphocytes, monocytes), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration ( MCHC), and red cell distribution width (RDW).

    • Tumor necrosis factor (TNF-α) is a proinflammatory factor that increases during ARDS.
    • Procalcitonin (PCT) is a peptide precursor of the hormone calcitonin, the latter being involved with calcium homeostasis.
    • D-dimer is a protein fragment that is released when a blood clot breaks down.
    • Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) are an enzyme produced by the liver.

  25. Laboratorium (Whole blood, TNF-α, Procalcitonin, D-dimer, SGOT, SGPT

    Time frame: days 13

    Whole blood check includes of hemoglobin (Hb), hematocrit (Ht), erythrocytes, leukocytes, platelets, type count (basophiles, eosinophils, lymphocytes, monocytes), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration ( MCHC), and red cell distribution width (RDW).

    • Tumor necrosis factor (TNF-α) is a proinflammatory factor that increases during ARDS.
    • Procalcitonin (PCT) is a peptide precursor of the hormone calcitonin, the latter being involved with calcium homeostasis.
    • D-dimer is a protein fragment that is released when a blood clot breaks down.
    • Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) are an enzyme produced by the liver.

  26. Laboratorium (Whole blood, TNF-α, Procalcitonin, D-dimer, SGOT, SGPT

    Time frame: days 14

    Whole blood check includes of hemoglobin (Hb), hematocrit (Ht), erythrocytes, leukocytes, platelets, type count (basophiles, eosinophils, lymphocytes, monocytes), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration ( MCHC), and red cell distribution width (RDW).

    • Tumor necrosis factor (TNF-α) is a proinflammatory factor that increases during ARDS.
    • Procalcitonin (PCT) is a peptide precursor of the hormone calcitonin, the latter being involved with calcium homeostasis.
    • D-dimer is a protein fragment that is released when a blood clot breaks down.
    • Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) are an enzyme produced by the liver.

  27. Laboratorium (Whole blood, TNF-α, Procalcitonin, D-dimer, SGOT, SGPT

    Time frame: days 28

    Whole blood check includes of hemoglobin (Hb), hematocrit (Ht), erythrocytes, leukocytes, platelets, type count (basophiles, eosinophils, lymphocytes, monocytes), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration ( MCHC), and red cell distribution width (RDW).

    • Tumor necrosis factor (TNF-α) is a proinflammatory factor that increases during ARDS.
    • Procalcitonin (PCT) is a peptide precursor of the hormone calcitonin, the latter being involved with calcium homeostasis.
    • D-dimer is a protein fragment that is released when a blood clot breaks down.
    • Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) are an enzyme produced by the liver.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia R Retna Sartika, Dr

CONTACT

[email protected]

+62811155048

Dewiyana Andari Kusmana

CONTACT

[email protected]

+6281290885529

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Collaborators

  • Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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