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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: Control (NaCl 0.9%); Biological: UC-MSC; Biological: UC-MSC and Secretome

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Dewiyana Andari Kusmana; Phone Number: +6281290885529; Email: dewiyana.ku@gmail.com
• Study Contact Backup: Name: Cynthia R Retna Sartika, Dr; Phone Number: +62811155048; Email: c.sartika@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10410
      • Recruiting
      • RSPAD Gatot Soebroto
      • Contact: dr. Dewiyana Andari Kusmana, SpP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: NaCl 0.9%; 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%); 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)
Experimental: Umbilical Cord Mesenchymal Stem Cell (UC-MSC); 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; 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)
Experimental: Mesenchymal Stem Cell (UC-MSC) + Secretome; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: PT. Prodia Stem Cell Indonesia
• Collaborators: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
• Investigators: Study Chair: Rima Haifa, B.Sc, Prodia StemCell Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mesenchymal Stem Cells; Acute Respiratory Distress Syndrome; Secretome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Metabolism; Chlorides; Hydrochloric Acid; Metabolome; Standard of Care; Sodium Chloride; Secretome
• Other Study ID Numbers: CT/SPS/05/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No