A Phase 1 interventional study of Secretome injection and Vitamin B12 Injection in Dementia and Moderate Dementia, sponsored by Baermed. Not yet recruiting at 1 site in Indonesia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Baermed · Phase 1, Interventional, and Treatment
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:
Participants will
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 54 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Baermed is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patient will receive secretome injection every two weeks for four months
Drug: Secretome injection
patient will receive 1 ampule of vitamin b12 every two weeks for 4 months
Drug: Vitamin B12 Injection
Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months
Also known as: secretome, hucmsc
Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months
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
Plan to share: Yes — Case Report Form (all collected IPD)
Supporting information: Study protocol, Icf, Csr
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Baermed