Panti Werda Hana
Tangeran Selatan, Banten, 15431, Indonesia
NCT Number: NCT06632470
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 opening soon.
Get Notified60 year and older
All sexes
Interventional
Phase 1
Tangeran Selatan, Banten, 15431, Indonesia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months
Other names: secretome, hucmsc
Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months
Time frame: From enrollment to 3 months after treatment
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
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
Participants achieved a response if there is a decrease in GFAP levels
Contact information is provided by the study sponsor or research team.
Dr. dr. Siufui Hendrawan, M. Biomed
CONTACT
Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ
CONTACT
Baermed
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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