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

ConditionAcute Respiratory Distress Syndrome
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Control (NaCl 0.9%)

    Other intervention

    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.

  • UC-MSC

    Biological/Vaccine

    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.

  • UC-MSC and Secretome

    Biological/Vaccine

    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.

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: NaCl 0.9%Placebo comparator 1 intervention
Group B: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)Experimental treatment 1 intervention
Group C: Mesenchymal Stem Cell (UC-MSC) + SecretomeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PT. Prodia Stem Cell Indonesia

Lead sponsor

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Collaborator

Source ClinicalTrials.gov
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