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

NCT06632470 | Not Yet Recruiting Phase 1

• 1 other identifier: 018-UTHREC/UNTAR/VIII/2024
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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

Conditions

Dementia; Moderate Dementia

Keywords

dementia; moderate dementia; neurocognitive impairment; secretome; HUCSMC; stem cells

Outcome Measures

Primary Outcomes (3)

• 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

  The blood parameters such as hemoglobin, hematocrit, leukocyte, thrombocyte, HbA1c, kidney function and liver function normal range is measured according to international standard

  From enrollment to 3 months after treatment

• Number of participants with improved Mini mental status examination, mini cog and AD8

  Participants achieved a response if they have improvement of MMSE score, mini cog score and AD8 score

  from enrollment to 3 months after treatment

• Number of participants with improved Glial Fibrillary Acid Protein (GFAP) levels

  Participants achieved a response if there is a decrease in GFAP levels

  from enrollment to 3 months after treatment

Study Arms (2)

Secretome injection

EXPERIMENTAL

patient will receive secretome injection every two weeks for four months

Drug: Secretome injection

Vitamin B12

PLACEBO COMPARATOR

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

Drug: Vitamin B12 Injection

Interventions

Secretome injection DRUG

Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months

Also known as: secretome, hucmsc

Secretome injection

Vitamin B12 Injection DRUG

Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months

Vitamin B12

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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

Sponsors & Collaborators

• Baermed: lead
• Tarumanagara University: collaborator
• panti werda hana: collaborator
• LPPT TARUMANAGARA: collaborator

Study Sites (1)

Panti Werda Hana

Tangeran Selatan, Banten, 15431, Indonesia

Location

Related Publications (20)

• 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 BACKGROUND

• 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.

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• 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 BACKGROUND

• 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.

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• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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.

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  PMID: 27529826 BACKGROUND

• 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.

  PMID: 38222245 BACKGROUND

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• 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.

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Related Links

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MeSH Terms

Conditions

Dementia

Interventions

Secretome; Vitamin B 12

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metabolome; Metabolism; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ

  Tarumanagara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ

CONTACT

+628119211219; saelan_untar@yahoo.co.id

Dr. dr. Siufui Hendrawan, M. Biomed

CONTACT

+628156963254; siufui@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: October 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: October 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After publication with no end date

Locations

ID (1)