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

NCT06632470 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-10-09

No results posted yet for this study

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

Conditions

Interventions

DRUG

Secretome injection

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

DRUG

Vitamin B12 Injection

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

Sponsors & Collaborators

  • Tarumanagara University

    collaborator OTHER

  • panti werda hana

    collaborator UNKNOWN

  • LPPT TARUMANAGARA

    collaborator UNKNOWN

  • Baermed

    lead OTHER

Principal Investigators

  • Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ · Tarumanagara University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-05-15
Completion
2025-10-01

Countries

  • Indonesia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06632470 on ClinicalTrials.gov