Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)

StatusUnknown
PhasePhase 1
SponsorBaermed
Started

Record status This record was last updated October 9, 2024 (before its estimated May 15, 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
3 trials monitored
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The goal of this clinical trial if to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with moderate dementia. The main questions it aims to answer are: 1. Is HUCMSC derived secretome safe to be use as a therapy in patients with moderate dementia? 2. How does HUCMSC derived secretome affect pro inflammatory and anti inflammatory cytokine (IL-6 and TNF alfa) in patient with moderate dementia? 3. What is the relationship between HUCMSC derived secretome therapy with mini mental state examination? Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored) Participants will * Be injected with HUCMSC derived secretome or Vitamin B12 every two weeks for 4 months * Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment) and participants will do several blood test and mental examination
Trial Details
NCT Number NCT06632470
Lead Sponsor Baermed
Collaborators: Tarumanagara University, panti werda hana, LPPT TARUMANAGARA
Conditions
(from sponsor)
Dementia, Moderate Dementia
Related terms Dementia
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov