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

What Was Tested

This registered phase 1 trial tested Cyanocobalamin (Vitamin B12).

The main questions it aims to answer are: 1.

It had two arms (groups): Secretome injection (experimental) and Vitamin B12 (placebo comparator).

Patient will receive secretome injection every two weeks for four months.

Patient will receive 1 ampule of vitamin b12 every two weeks for 4 months.

The registry classes the interventions as drug.

Who Took Part

54 planned participants were the target.

It was open to people of any sex aged from 60 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 with care giver or supporting family who can assist patient with research protocol.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.

It started in 2024-10-15 with completion listed for 2025-05-15.

It ran at 1 site in Indonesia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Cyanocobalamin (Vitamin B12) in 54 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.