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
Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Indonesia
RSPAD Gatot Soebroto
RECRUITING
Jakarta Pusat
Contact Information
Primary
Dewiyana Andari Kusmana
dewiyana.ku@gmail.com
+6281290885529
Backup
Cynthia R Retna Sartika, Dr
c.sartika@gmail.com
+62811155048
Time Frame
Start Date: 2023-12-25
Estimated Completion Date: 2026-12
Participants
Target number of participants: 15
Treatments
Placebo_comparator: NaCl 0.9%
5 acute ARDS patients will be given: 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.
Experimental: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
5 acute ARDS patients will be given: 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.
Experimental: Mesenchymal Stem Cell (UC-MSC) + Secretome
5 acute ARDS patients will be given: 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.
Related Therapeutic Areas
Sponsors
Leads: PT. Prodia Stem Cell Indonesia
Collaborators: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto