NCT06632470 · Phase 1 · NOT YET RECRUITING
Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)
This trial is testing whether a secretome — a mix of proteins and signals released by stem cells from umbilical cord tissue — is safe and has any effect on inflammation and cognition in people with moderate dementia. Vitamin B12 injections are used as the comparison treatment. It is a Phase 1 trial, meaning the primary focus is on safety in humans for the first time, not proving that it works.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-10-09