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NOT YET RECRUITING
NCT06632470
PHASE1

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

Sponsor: Baermed

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2024-10-15

Completion Date

2025-10-01

Last Updated

2024-10-09

Healthy Volunteers

No

Interventions

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

Locations (1)

Panti Werda Hana

Tangeran Selatan, Banten, Indonesia