Clinical trial NCT06632470: Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)
Official title: Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Dementia
Moderate Dementia
Keywords: dementia
moderate dementia
neurocognitive impairment
secretome
HUCSMC
stem cells
Lead sponsor: Baermed
Sponsor class: OTHER
Collaborators: name: Tarumanagara University
name: panti werda hana
name: LPPT TARUMANAGARA
First posted: 2024-10-09
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Age \&gt; 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

Primary outcomes:
measure: 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
timeFrame: From enrollment to 3 months after treatment
measure: Number of participants with improved Mini mental status examination, mini cog and AD8
timeFrame: from enrollment to 3 months after treatment
measure: Number of participants with improved Glial Fibrillary Acid Protein (GFAP) levels
timeFrame: from enrollment to 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tangeran Selatan
country: Indonesia
facility: Panti Werda Hana
state: Banten
Study officials:
affiliation: Tarumanagara University
name: Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ
role: PRINCIPAL_INVESTIGATOR
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