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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• RSPAD Gatot Soebroto
  Jakarta Pusat, DKI Jakarta, Indonesia Recruiting

Study contacts

• Study coordinator: Dewiyana Andari Kusmana
• Email: dewiyana.ku@gmail.com
• Phone: +6281290885529

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.