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

October 7, 2024 updated by: Baermed

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dr. dr. Siufui Hendrawan, M. Biomed
  • Phone Number: +628156963254
  • Email: siufui@gmail.com

Study Locations

  • Indonesia
    • Banten
      • Tangeran Selatan, Banten, Indonesia, 15431
        • Panti Werda Hana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Secretome injection
patient will receive secretome injection every two weeks for four months
Drug: Secretome injection
Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months
Other Names:
  • secretome
  • hucmsc
Placebo Comparator: Vitamin B12
patient will receive 1 ampule of vitamin b12 every two weeks for 4 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to 3 months after treatment
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
from enrollment to 3 months after treatment
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
from enrollment to 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baermed

Collaborators

Tarumanagara University
panti werda hana
LPPT TARUMANAGARA

Investigators

  • Principal Investigator: Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ, Tarumanagara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 018-UTHREC/UNTAR/VIII/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Case Report Form (all collected IPD)

IPD Sharing Time Frame

After publication with no end date

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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