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NCT06632470

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

Not yet recruiting Phase 1 Last updated 9 October 2024
What this trial tests

Phase 1 trial testing Secretome injection in Dementia in 54 participants. Not yet recruiting.

Timeline
15 October 2024
Primary endpoint
15 May 2025
1 October 2025

Quick facts

Lead sponsorBaermed
PhasePhase 1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment54
Start date15 October 2024
Primary completion15 May 2025
Estimated completion1 October 2025
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Baermed

Who can join

60 and older, any sex, with Dementia or Moderate Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Biological Nanotherapeutics Derived From Human Umbilical Cord Mesenchymal Stem Cells: Mechanisms and Translational Potential in Multisystem Therapies for Regeneration and Oncology.
    Zhang R, Xu Z, Xu S, Li R, et al · · 2025 · cited 3× · PMID 41078403 · DOI 10.2147/ijn.s550390

Verify or expand the search:

Other recruiting trials for Dementia

Currently open trials in the same condition.

Other Baermed trials

Trials by the same sponsor.

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Data sources for this page

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