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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
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.
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.
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.
RSPAD Gatot Soebroto
Jakarta Pusat, DKI Jakarta, Indonesia
RECRUITINGLung 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: days 28