Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)
NCT ID: NCT06632470
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
54 participants
INTERVENTIONAL
2024-10-15
2025-10-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Secretome injection
patient will receive secretome injection every two weeks for four months
Secretome injection
Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months
Vitamin B12
patient will receive 1 ampule of vitamin b12 every two weeks for 4 months
Vitamin B12 Injection
Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months
Interventions
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Secretome injection
Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months
Vitamin B12 Injection
Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
60 Years
ALL
No
Sponsors
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Tarumanagara University
OTHER
panti werda hana
UNKNOWN
LPPT TARUMANAGARA
UNKNOWN
Baermed
OTHER
Responsible Party
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Principal Investigators
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Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ
Role: PRINCIPAL_INVESTIGATOR
Tarumanagara University
Locations
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Panti Werda Hana
Tangeran Selatan, Banten, Indonesia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Treanor CJ, McMenamin UC, O'Neill RF, Cardwell CR, Clarke MJ, Cantwell M, Donnelly M. Non-pharmacological interventions for cognitive impairment due to systemic cancer treatment. Cochrane Database Syst Rev. 2016 Aug 16;2016(8):CD011325. doi: 10.1002/14651858.CD011325.pub2.
Hafiz R, Alajlani L, Ali A, Algarni GA, Aljurfi H, Alammar OAM, Ashqan MY, Alkhashan A. The Latest Advances in the Diagnosis and Treatment of Dementia. Cureus. 2023 Dec 14;15(12):e50522. doi: 10.7759/cureus.50522. eCollection 2023 Dec.
Salomone S, Caraci F, Leggio GM, Fedotova J, Drago F. New pharmacological strategies for treatment of Alzheimer's disease: focus on disease modifying drugs. Br J Clin Pharmacol. 2012 Apr;73(4):504-17. doi: 10.1111/j.1365-2125.2011.04134.x.
Pierre G. Neurodegenerative disorders and metabolic disease. Arch Dis Child. 2013 Aug;98(8):618-24. doi: 10.1136/archdischild-2012-302840. Epub 2013 May 22.
Zriek F, Di Battista JA, Alaaeddine N. Mesenchymal Stromal Cell Secretome: Immunomodulation, Tissue Repair and Effects on Neurodegenerative Conditions. Curr Stem Cell Res Ther. 2021;16(6):656-669. doi: 10.2174/1574888X16666210202145639.
Guo J, Huang X, Dou L, Yan M, Shen T, Tang W, Li J. Aging and aging-related diseases: from molecular mechanisms to interventions and treatments. Signal Transduct Target Ther. 2022 Dec 16;7(1):391. doi: 10.1038/s41392-022-01251-0.
Morrone A, Donini LM, Scardella P, Piombo L, Pinto A, Giusti AM, Neri B, Hagedorn T, Proietti AR, Cataldi S, Cucinotta D, Di Bella G, Barbagallo M, Cannella C; Gruppo di Lavoro MEG. [Malnutrition in the elderly: clinical features, psychological and social determinants. Preliminary results]. Ann Ig. 2011 Mar-Apr;23(2):161-72. Italian.
Bhatia MS, Srivastava S, Moond V. Prevalence of cognitive dysfunction, psychological morbidity and abuse in the community-based elderly population in India. Gen Psychiatr. 2020 Aug 16;33(5):e100207. doi: 10.1136/gpsych-2020-100207. eCollection 2020.
Ezkurdia A, Ramirez MJ, Solas M. Metabolic Syndrome as a Risk Factor for Alzheimer's Disease: A Focus on Insulin Resistance. Int J Mol Sci. 2023 Feb 22;24(5):4354. doi: 10.3390/ijms24054354.
Emmady PD, Schoo C, Tadi P. Major Neurocognitive Disorder (Dementia). 2022 Nov 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557444/
Rasmussen KL, Frikke-Schmidt R. The current state of apolipoprotein E in dyslipidemia. Curr Opin Lipidol. 2024 Apr 1;35(2):78-84. doi: 10.1097/MOL.0000000000000915. Epub 2023 Dec 6.
Shen C, Liu C, Qiu A. Metabolism-related brain morphology accelerates aging and predicts neurodegenerative diseases and stroke: a UK Biobank study. Transl Psychiatry. 2023 Jun 29;13(1):233. doi: 10.1038/s41398-023-02515-1.
Related Links
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Related Info
Other Identifiers
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018-UTHREC/UNTAR/VIII/2024
Identifier Type: -
Identifier Source: org_study_id
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