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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months
Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months
Panti Werda Hana
Tangeran Selatan, Banten, Indonesia
Number of moderate dementia patients with normal range of blood parameters assessed by hemoglobin level, hematocrit level, leukocyte level, thrombocyte level, HbA1c level, kidney function and liver function
The blood parameters such as hemoglobin, hematocrit, leukocyte, thrombocyte, HbA1c, kidney function and liver function normal range is measured according to international standard
Time frame: From enrollment to 3 months after treatment
Number of participants with improved Mini mental status examination, mini cog and AD8
Participants achieved a response if they have improvement of MMSE score, mini cog score and AD8 score
Time frame: from enrollment to 3 months after treatment
Number of participants with improved Glial Fibrillary Acid Protein (GFAP) levels
Participants achieved a response if there is a decrease in GFAP levels
Time frame: from enrollment to 3 months after treatment
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