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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
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
-
-
DKI Jakarta
-
Jakarta Pusat, DKI Jakarta, Indonesia, 10410
- Recruiting
- RSPAD Gatot Soebroto
-
Contact:
- dr. Dewiyana Andari Kusmana, SpP
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
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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:
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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.
|
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:
|
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Before therapy
|
|
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.
|
days 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.
|
days 6
|
|
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.
|
days 13
|
|
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.
|
days 14
|
|
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.
|
days 28
|
|
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.
|
Before therapy
|
|
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.
|
days 3
|
|
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.
|
days 6
|
|
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.
|
days 13
|
|
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.
|
days 14
|
|
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.
|
days 28
|
|
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.
|
Before therapy
|
|
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.
|
days 3
|
|
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.
|
days 6
|
|
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.
|
days 13
|
|
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.
|
days 14
|
|
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.
|
days 28
|
|
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. |
Before therapy
|
|
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. |
days 6
|
|
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. |
days 13
|
|
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).
|
Before therapy
|
|
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).
|
days 3
|
|
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).
|
days 6
|
|
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).
|
days 13
|
|
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).
|
days 14
|
|
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).
|
days 28
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Rima Haifa, B.Sc, Prodia StemCell Indonesia
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
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
Other Study ID Numbers
- CT/SPS/05/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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