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

Обзор

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

Вмешательства

• Препарат Secretome injection
  Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months
• Препарат Vitamin B12 Injection
  Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months

Первичные конечные точки

• 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 [Срок оценки: From enrollment to 3 months after treatment]
• Number of participants with improved Mini mental status examination, mini cog and AD8 [Срок оценки: from enrollment to 3 months after treatment]
• Number of participants with improved Glial Fibrillary Acid Protein (GFAP) levels [Срок оценки: from enrollment to 3 months after treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Panti Werda Hana — Tangeran Selatan

Публикации

• Chiu EC, Chien TH, Lee YC. Measurement Equivalence between the Original and Estimated Mini-Mental State Examination in People with Dementia. Int J Environ Res Public Health. 2021 Jul 17;18(14):7616. doi: 10.3390/ijerph18147616. PMID 34300067
• Myrberg K, Hyden LC, Samuelsson C. The mini-mental state examination (MMSE) from a language perspective: an analysis of test interaction. Clin Linguist Phon. 2020 Jul 2;34(7):652-670. doi: 10.1080/02699206.2019.1687757. Epub 2019 Nov 18. PMID 31739693
• Arevalo-Rodriguez I, Smailagic N, Roque I Figuls M, Ciapponi A, Sanchez-Perez E, Giannakou A, Pedraza OL, Bonfill Cosp X, Cullum S. Mini-Mental State Examination (MMSE) for the detection of Alzheimer's disease and other dementias in people with mild cognitive impairment (MCI). Cochrane Database Syst Rev. 2015 Mar 5;2015(3):CD010783. doi: 10.1002/14651858.CD010783.pub2. PMID 25740785
• Thanaskody K, Jusop AS, Tye GJ, Wan Kamarul Zaman WS, Dass SA, Nordin F. MSCs vs. iPSCs: Potential in therapeutic applications. Front Cell Dev Biol. 2022 Nov 2;10:1005926. doi: 10.3389/fcell.2022.1005926. eCollection 2022. PMID 36407112
• Lee C, Kim M, Han J, Yoon M, Jung Y. Mesenchymal Stem Cells Influence Activation of Hepatic Stellate Cells, and Constitute a Promising Therapy for Liver Fibrosis. Biomedicines. 2021 Nov 2;9(11):1598. doi: 10.3390/biomedicines9111598. PMID 34829827
• Teixeira FG, Panchalingam KM, Assuncao-Silva R, Serra SC, Mendes-Pinheiro B, Patricio P, Jung S, Anjo SI, Manadas B, Pinto L, Sousa N, Behie LA, Salgado AJ. Modulation of the Mesenchymal Stem Cell Secretome Using Computer-Controlled Bioreactors: Impact on Neuronal Cell Proliferation, Survival and Differentiation. Sci Rep. 2016 Jun 15;6:27791. doi: 10.1038/srep27791. PMID 27301770
• Willis CM, Nicaise AM, Hamel R, Pappa V, Peruzzotti-Jametti L, Pluchino S. Harnessing the Neural Stem Cell Secretome for Regenerative Neuroimmunology. Front Cell Neurosci. 2020 Nov 5;14:590960. doi: 10.3389/fncel.2020.590960. eCollection 2020. PMID 33250716
• Park JH, Jung SJ, Lee LJ, Rhu J, Bae SH. Impact of nonpharmacological interventions on cognitive impairment in women with breast cancer: A systematic review and meta-analysis. Asia Pac J Oncol Nurs. 2023 Mar 1;10(4):100212. doi: 10.1016/j.apjon.2023.100212. eCollection 2023 Apr. PMID 37095894

Идентификаторы

NCT: NCT06632470 · 018-UTHREC/UNTAR/VIII/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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