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

NCT07439848 | Recruiting Phase 1 DMC

• 1 other identifier: CT/SPS/05/2024
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; Mesenchymal Stem Cells; Secretome

Outcome Measures

Primary Outcomes (27)

• Lung Injury Score

  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.

  Before therapy

• Lung Injury Score

  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.

  days 3

• Lung Injury Score

  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.

  days 6

• Lung Injury Score

  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.

  days 13

• Lung Injury Score

  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.

  days 14

• Lung Injury Score

  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.

  days 28

• Sequential organ Failure Assessment Score (SOFA)

  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.

  Before therapy

• Sequential organ Failure Assessment Score (SOFA)

  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.

  days 3

• Sequential organ Failure Assessment Score (SOFA)

  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.

  days 6

• Sequential organ Failure Assessment Score (SOFA)

  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.

  days 13

• Sequential organ Failure Assessment Score (SOFA)

  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.

  days 14

• Sequential organ Failure Assessment Score (SOFA)

  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.

  days 28

• Acute Physiology and Chronic Health Evaluation Score (APACHE)

  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.

  Before therapy

• Acute Physiology and Chronic Health Evaluation Score (APACHE)

  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.

  days 3

• Acute Physiology and Chronic Health Evaluation Score (APACHE)

  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.

  days 6

• Acute Physiology and Chronic Health Evaluation Score (APACHE)

  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.

  days 13

• Acute Physiology and Chronic Health Evaluation Score (APACHE)

  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.

  days 14

• Acute Physiology and Chronic Health Evaluation Score (APACHE)

  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.

  days 28

• Laboratorium (IL-6 IL-12)

  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.

  Before therapy

• Laboratorium (IL-6 IL-12)

  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.

  days 6

• Laboratorium (IL-6 IL-12)

  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.

  days 13

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

  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.

  Before therapy

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

  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.

  days 3

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

  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.

  days 6

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

  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.

  days 13

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

  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.

  days 14

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

  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.

  days 28

Study Arms (3)

NaCl 0.9%

PLACEBO COMPARATOR

5 acute ARDS patients will be given: 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: Control (NaCl 0.9%)

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

EXPERIMENTAL

5 acute ARDS patients will be given: 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

Mesenchymal Stem Cell (UC-MSC) + Secretome

EXPERIMENTAL

5 acute ARDS patients will be given: 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.

Biological: UC-MSC and Secretome

Interventions

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.

Also known as: Standard of Care (SoC)

NaCl 0.9%

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.

Also known as: Umbilical Cord- Mesenchymal Stem Cell (UC-MSC)

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.

Also known as: Umbilical Cord- Mesenchymal Stem Cell (UC-MSCS) and Secretome

Mesenchymal Stem Cell (UC-MSC) + Secretome

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PT. Prodia Stem Cell Indonesia: lead
• Rumah Sakit Pusat Angkatan Darat Gatot Soebroto: collaborator

Study Sites (1)

RSPAD Gatot Soebroto

Jakarta Pusat, DKI Jakarta, 10410, Indonesia

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Sodium Chloride; Standard of Care; Secretome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Metabolome; Metabolism

Study Officials

• Rima Haifa, B.Sc

  Prodia StemCell Indonesia

  STUDY CHAIR

Central Study Contacts

Dewiyana Andari Kusmana

CONTACT

+6281290885529; dewiyana.ku@gmail.com

Cynthia R Retna Sartika, Dr

CONTACT

+62811155048; c.sartika@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This type of research is Double Blind Randomized Control Trial Experimental Research or different experimental research.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: February 27, 2026
• Study Start: December 25, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

ID (1)