Mesenchymal Stem Cells (MSCs) and Conditioned Medium Mesenchymal Stem Cells as Adjuvant Therapy for Sepsis

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorPT. Prodia Stem Cell Indonesia

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

15 Participants
are divided into 3 treatment groups

Sponsors and collaborators

PT. Prodia Stem Cell Indonesia

Lead sponsor

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Collaborator