Umbilical‑cord mesenchymal stem cell and secretome therapy for severe ARDS

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

This trial tests whether IV umbilical‑cord mesenchymal stem cells, alone or with secretome, help adults with severe ARDS recover lung function and reduce inflammation.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: PT. Prodia Stem Cell Indonesia (industry)
• Locations: 1 site (Jakarta Pusat, DKI Jakarta)
• Trial ID: NCT07439848 on ClinicalTrials.gov

What this trial studies

This randomized, double‑blind, three‑arm Phase 1/2 trial compares standard care with intravenous umbilical cord mesenchymal stem cells (UC‑MSC) alone and UC‑MSC plus secretome in patients with severe ARDS. Secretome doses (2 mL) are given on days 1, 4, and 7 and UC‑MSC (1 x 10^6 cells/kg) on days 2, 5, and 8, with saline used for the control arm. Outcomes include a composite lung injury score (chest X‑ray, hypoxemia, PEEP, and respiratory compliance) and laboratory markers including CBC, D‑dimer, procalcitonin, CRP, IL‑6, IL‑12, and TNF‑α. Patients are categorized post‑treatment as no lung injury, mild‑moderate, or severe to compare group effects on recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 or older with severe ARDS by the Berlin criteria whose families consent to participate and who are able to receive on‑site treatment at the study hospital.

Not a fit: Patients unlikely to benefit include pregnant women, those with very poor liver or kidney function (e.g., eGFR <30 ml/min or SGOT/SGPT >5× normal), people with more than two major comorbidities, or those with extreme lipid abnormalities.

Why it matters

Potential benefit: If successful, the therapy could shorten lung injury, lower inflammation, and reduce illness severity in adults with severe ARDS.

How similar studies have performed: Early‑phase MSC trials in ARDS have shown acceptable safety and some signals of improved oxygenation, but clear clinical benefit is not yet proven and adding secretome is a relatively novel approach.

Eligibility criteria

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

Where this trial is running

Jakarta Pusat, DKI Jakarta

• RSPAD Gatot Soebroto — Jakarta Pusat, DKI Jakarta, Indonesia (RECRUITING)

Study contacts

• Study coordinator: Dewiyana Andari Kusmana

Conditions: Acute Respiratory Distress Syndrome, Mesenchymal Stem Cells, Secretome