A Phase 1/2 interventional study of Control (NaCl 0.9%) and UC-MSC in Acute Respiratory Distress Syndrome, sponsored by PT. Prodia Stem Cell Indonesia. Recruiting at 1 site in Indonesia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by PT. Prodia Stem Cell Indonesia · Phase 1/2, Interventional, and Treatment
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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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →PT. Prodia Stem Cell Indonesia is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%)
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
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 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)
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)
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
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: 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.
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
Started Dec 2023 (actual). Primary completion is estimated for Dec 2026, 36 months after the start.
Of 25 phase 1/2 interventional studies under Respiratory Distress Syndrome, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 23. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Solizmestrocel
Respiratory Distress Syndrome →
PT. Prodia Stem Cell Indonesia