About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Control (NaCl 0.9%)
- UC-MSC
- UC-MSC and Secretome
Treatment groups
Sponsors and collaborators
PT. Prodia Stem Cell Indonesia
Lead sponsor
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Collaborator