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

Launched by BAERMED · Oct 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into whether an injection made from Human Umbilical Cord Mesenchymal Stem Cell secretome is safe and effective for people with moderate dementia. The researchers want to find out if this treatment can help reduce inflammation in the brain and improve cognitive function, which is measured using a simple memory test. Participants will either receive this treatment or a Vitamin B12 injection every two weeks for four months, and then they will have follow-up visits to check on their health and progress.

To be eligible for this study, participants need to be over 60 years old and have a confirmed diagnosis of moderate dementia. It’s important that they are stable and not dealing with any severe medical conditions that could complicate the trial. Caregivers or family members will also be required to help support the participants throughout the study. If you or someone you know is interested in learning more, please keep an eye out for when the study starts recruiting participants!

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Eligibility criteria

• 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