NCT06632470

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Baermed · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Dementia
• Moderate Dementia

Interventions

Type	Name	Description
DRUG	Secretome injection	Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months
DRUG	Vitamin B12 Injection	Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-05-15
• Completion: 2025-10-01
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: Indonesia