NCT07439848 Mesenchymal Stem Cells (MSCs) and Conditioned Medium Mesenchymal Stem Cells as Adjuvant Therapy for Sepsis
| NCT ID | NCT07439848 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | PT. Prodia Stem Cell Indonesia |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-12-25 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2023-12-25 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Rima Haifa, B.Sc
STUDY CHAIR
Prodia StemCell Indonesia
Frequently Asked Questions
Who can join the NCT07439848 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07439848 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07439848 currently recruiting?
Yes, NCT07439848 is actively recruiting participants. Contact the research team at dewiyana.ku@gmail.com for enrollment information.
Where is the NCT07439848 trial being conducted?
This trial is being conducted at Jakarta Pusat, Indonesia.
Who is sponsoring the NCT07439848 clinical trial?
NCT07439848 is sponsored by PT. Prodia Stem Cell Indonesia. The principal investigator is Rima Haifa, B.Sc at Prodia StemCell Indonesia. The trial plans to enroll 15 participants.