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NCT Number: NCT06632470

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

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patient undergoing stable dose treatment for other medical condition at least 4 months before the trial
  • Patient with care giver or supporting family who can assist patient with research protocol

Exclusion criteria

  • 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
  • Patient who has allergy or hypersensitivity reaction towards secretome
  • Patient with medical complications or surgery complications that require immediate interventions or other life threatening complications
  • Patient is unable to provide written informed consent and not capable to understand and comply to research protocol
  • Patient is unwilling and not capable to follow research protocol including follow up evaluations and blood sampling according to schedule

Treatment and study plan

Secretome injection

Drug

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

Other names: secretome, hucmsc

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

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

    Time frame: 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

  2. Number of participants with improved Mini mental status examination, mini cog and AD8

    Time frame: from enrollment to 3 months after treatment

    Participants achieved a response if they have improvement of MMSE score, mini cog score and AD8 score

  3. Number of participants with improved Glial Fibrillary Acid Protein (GFAP) levels

    Time frame: from enrollment to 3 months after treatment

    Participants achieved a response if there is a decrease in GFAP levels

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. dr. Siufui Hendrawan, M. Biomed

CONTACT

[email protected]

+628156963254

Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ

CONTACT

[email protected]

+628119211219

Sponsors and collaborators

Lead sponsor

Baermed

Other

Collaborators

  • LPPT TARUMANAGARA
  • Tarumanagara University
  • panti werda hana

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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