Acute Respiratory Distress Syndrome
Conditions
Keywords
Acute Respiratory Distress Syndrome, Mesenchymal Stem Cells, Secretome
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.
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.
Interventions
BIOLOGICALUC-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.
BIOLOGICALUC-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.
OTHERControl (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.
Sponsors
PT. Prodia Stem Cell Indonesia
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Intervention model description
This type of research is Double Blind Randomized Control Trial Experimental Research or different experimental research.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Injury Score | 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. |
| Sequential organ Failure Assessment Score (SOFA) | 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. |
| Acute Physiology and Chronic Health Evaluation Score (APACHE) | 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. |
| Laboratorium (IL-6 IL-12) | 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. |
| Laboratorium (Whole blood, TNF-α, Procalcitonin, D-dimer, SGOT, SGPT | 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). * 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. |
Countries
Indonesia
Contacts
CONTACTDewiyana Andari Kusmana
CONTACTCynthia R Retna Sartika, Dr
STUDY_CHAIRRima Haifa, B.Sc
Prodia StemCell Indonesia
Outcome results
None listed