Dementia, Moderate Dementia
Conditions
Keywords
dementia, moderate dementia, neurocognitive impairment, secretome, HUCSMC, stem cells
Brief 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
Interventions
DRUGSecretome injection
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
Sponsors
Tarumanagara University
panti werda hana
LPPT TARUMANAGARA
Baermed
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age > 60 years old 2. Patient diagnosed with dementia confirmed by psychiatrist or neurologist based on DSM-4 or ICD 10 3. Patient with Mini-Mental State Examination (MMSE) between 10 to 20 indicating moderate cognitive impairment 4. Patient is in stable condition without life threatening disease or uncontrolled medical condition 5. Patient undergoing stable dose treatment for other medical condition at least 4 months before the trial 6. Patient with care giver or supporting family who can assist patient with research protocol
Exclusion criteria
1. Patient has dementia due to other medical condition such as severe head trauma, brain infection or history of drug abuse 2. Patient with uncontrolled medical condition such as severe cardiovascular disease, chronic lung disease, cancer, or systemic infection 3. Patient with severe psychiatry disorder such as schizophrenia and bipolar disorder 4. Patient is receiving experimental drugs or participates in experimental studies for the last 30 days before the trial 5. Patient who has allergy or hypersensitivity reaction towards secretome 6. Patient with medical complications or surgery complications that require immediate interventions or other life threatening complications 7. Patient is unable to provide written informed consent and not capable to understand and comply to research protocol 8. Patient is unwilling and not capable to follow research protocol including follow up evaluations and blood sampling according to schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Number of participants with improved Mini mental status examination, mini cog and AD8 | from enrollment to 3 months after treatment | Participants achieved a response if they have improvement of MMSE score, mini cog score and AD8 score |
| Number of participants with improved Glial Fibrillary Acid Protein (GFAP) levels | from enrollment to 3 months after treatment | Participants achieved a response if there is a decrease in GFAP levels |
Countries
Indonesia
Contacts
Primary ContactNoer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ
Backup ContactDr. dr. Siufui Hendrawan, M. Biomed
Outcome results
None listed