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Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)

ConditionsDementiaModerate Dementia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60+
SponsorBaermed

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age > 60 years old

Patient diagnosed with dementia confirmed by psychiatrist or neurologist based on DSM-4 or ICD 10

Patient with Mini-Mental State Examination (MMSE) between 10 to 20 indicating moderate cognitive impairment

Patient is in stable condition without life threatening disease or uncontrolled medical condition

Disqualifiers

Patient has dementia due to other medical condition such as severe head trauma, brain infection or history of drug abuse

Patient with uncontrolled medical condition such as severe cardiovascular disease, chronic lung disease, cancer, or systemic infection

Patient with severe psychiatry disorder such as schizophrenia and bipolar disorder

Patient is receiving experimental drugs or participates in experimental studies for the last 30 days before the trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • Secretome injection

    Drug

    Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months

  • Vitamin B12 Injection

    Drug

    Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Secretome injectionExperimental treatment 1 intervention
Group B: Vitamin B12Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Panti Werda Hana Status unavailable 15431, Tangeran Selatan, BantenIndonesiaIndonesia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baermed

Lead sponsor

Tarumanagara University

Collaborator

panti werda hana

Collaborator

LPPT TARUMANAGARA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: