Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Drug Resistant Epilepsy Single Center, Non-randomized, Phase I Clinical Trial

The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with epilepsy. The main questions it ams to answer are:
1. How is the relationship between secretome therapy and the reduction in seizure frequency and duration in patients with drug-resistant epilepsy in the adult age group?
2. How does secretome therapy affect EEG and qEEG results in patients with drug-resistant epilepsy in the adult age group?
3. How is the relationship between secretome therapy and the Mini Mental State Examination (MMSE) score in patients with drug-resistant epilepsy in the adult age group?
4. How does secretome therapy affect stress levels as measured by the Perceived Stress Scale (PSS) in patients with drug-resistant epilepsy in the adult age group?
5. How does secretome therapy affect Gait Deviation Index (GDI) scores in patients with drug-resistant epilepsy in the adult age group?
6. How does secretome therapy affect quality of life as measured by the Quality of Life in Epilepsy Inventory (QOLIE-31) in patients with drug-resistant epilepsy in the adult age group?

开始日期2024-12-01

申办/合作机构

Baermed

[+1]

NCT06629909

/ Not yet recruiting临床1期IIT

Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis: a Comprehensive Evaluation of Fibrosis Reduction, Immunomodulation, and Hepatic Regeneration a Single Center, Non-randomized, Phase I Clinical Trial

The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with liver cirrhosis. The main questions it ams to answer are:
1. How safe is secretome Injection as an adjuvant therapy for liver cirrhosis patients?
2. How effective is secretome injection in liver fibrosis 6 months after injection?
3. Does secretome injection improve liver function after 6 months after Injection?
4. Does secretome injection affect Child Turcotte Pugh score?
5. How does secretome affect pro inflammatory and anti Inflammatory cytokine in patient with liver cirrhosis?
6. How does secretome injection affect the quality of life in live cirrhosis patient?
7. What is the relationship between secretome injection and encephalopathy? Researchers will compare secretome injection group (patients who recieve secretome injections) to best practice treatment group (patient who receive supportive treatment including hepatoprotector and ursodeoxycolic acid)
Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored and given their usual drugs)
Patients will:
Be injected with secretome or take hepatoprotector and ursodeoxycolic acid every 2 weeks for 4 months. Do several test such us fibroscan, stroop test, psychometric hepatic encephalopathy score, short form 36 questionnaire, IL-6, TNF alfa and blood test for albumin, SGOT, SGPT, direct bilirubin, indirect bilirubin, INR, creatinine, ureum, hemoglobin, hematocrite, leukocyte, and thrombocyte.
Visit the clinic once every two weeks to receive drugs and treatment for 4 months.
Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment),10th months (6 months post treatment)

开始日期2024-12-01

申办/合作机构

Baermed

[+1]

NCT06632470

/ Not yet recruiting临床1期IIT

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

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

开始日期2024-10-15

申办/合作机构

Baermed

[+1]

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0 项与 Universitas Tarumanagara 相关的专利（医药）

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179

项与 Universitas Tarumanagara 相关的文献（医药）

2025-10-01·BEHAVIOUR RESEARCH AND THERAPY

A culturally adapted internet-delivered mindfulness intervention with counsellor guidance for reducing distress among Indonesian university students: A randomised waitlist-controlled trial

Article

作者: Andriani, Annisa ; Nirbayaningtyas, Rizky Bina ; Hafizah, Nurul ; Moulds, Michelle L ; Listiyandini, Ratih Arruum ; Sholeh, Achmad ; Newby, Jill M ; Marfu'atun, Elya ; Mahoney, Alison E J ; Afsari, Nyda

Psychological distress is prevalent among university students worldwide, including in Low- and Middle-Income Countries (LMICs) such as Indonesia. Internet-delivered mindfulness interventions have been found to reduce distress. However, studies that evaluate the effectiveness of internet-delivered mindfulness interventions in LMICs are very limited. This randomised wait-list controlled trial assessed the effectiveness of a culturally adapted internet-based mindfulness intervention with lay counsellor guidance for reducing distress among university students in Indonesia. Indonesian university students experiencing elevated distress (N = 156) were randomly allocated to a 4-lesson internet-based mindfulness program with counsellor guidance (n = 77) or wait-list control (WLC) group (n = 79) during 4 weeks of intervention. Both groups completed self-report measures assessing psychological distress (DASS-21 and K-10), mindfulness (FFMQ), and well-being (IWBS) at baseline (T0), post-treatment (T1-week 5 after randomization), and 1-month follow-up (T2-week 9 after randomization). Intention-to-treat linear mixed models showed that participants on the internet-based mindfulness program guided by lay counsellors showed greater improvements at post-treatment and 1-month follow-up in psychological distress and mindfulness (between-group Hedges' gs = 0.48-1.18) compared to the WLC group. Moderate between group effect sizes for wellbeing were found at 1-month follow-up (g = 0.47). This study showed that a culturally adapted internet-based mindfulness intervention with counsellor guidance is efficacious in reducing the psychological distress of Indonesian university students. Future research should evaluate the longer-term outcomes and its cost-effectiveness in Indonesia.

2025-07-29·MOLECULES

In Vitro and In Silico Evaluation of the Anti-Aging Potential of Eugenia uniflora UAE Extracts.

Article

作者: Yunita, Fenny ; Setyaningsih, Erwi Putri ; Elya, Berna ; Othman, Rozana ; Wenas, Desy Muliana ; Triadisti, Nita ; Sutriyo, Sutriyo ; Setiawan, Heri ; Nur, Syamsu

Skin aging is a natural biological process that can be accelerated by free radical induction, leading to a reduction in skin elasticity and the formation of wrinkles due to the depletion of elastin. Eugenia uniflora (dewandaru) is a promising plant believed to possess anti-aging properties, primarily attributed to its major constituents, myricitrin and quercetin. This study aimed to investigate the anti-elastase and antioxidant properties of Eugenia uniflora stem bark, ripe fruit, and seed extracts. Extracts were obtained using an ultrasound-assisted extraction (UAE) method with 70% ethanol. Quantitative phytochemical analysis involved measuring the total phenolic content (TPC), total flavonoid content (TFC), and antioxidant activity. Bioactive constituents were identified using LC-MS analysis, and their interactions with target enzymes were further evaluated through in silico molecular docking. The results demonstrated that the E. uniflora seed extract exhibited the highest antioxidant activity, with an IC₅₀ of 5.23 µg/mL (DPPH assay) and a FRAP value of 3233.32 µmol FeSO₄/g. Furthermore, the ethanolic seed extract showed significant anti-elastase activity with an IC₅₀ of 114.14 µg/mL. Molecular docking predicted strong potential for several compounds as pancreatic elastase inhibitors, including 5-phenylvaleric acid, 2-(3-phenylpropyl)phenol, n-amylbenzene, 2-aminoadipic acid, and traumatin, each showing a prediction activity (PA) value exceeding 0.6. Notably, these compounds also exhibited inhibitory activity against tyrosinase. These findings collectively underscore the significant promise of E. uniflora seed extract as a novel and natural candidate for pharmacocosmeceutical product development, particularly for anti-aging applications.

2025-04-01·Acta Medica Indonesiana

Early Enteral Feeding Versus Total Parenteral Feeding After Surgery in Severe Acute Pancreatitis: An Evidence-Based Case Report.

Article

作者: Pandapotan, Roy Akur ; Setiawan, Andre ; Citra, Nathalia Gracia ; Syafitri, Anissa ; Titus, Johana ; Bierhuijs, Josephine Alicia ; Gunawan, Burhan

BACKGROUND:

Acute pancreatitis is a self-limiting inflammatory disease that in some cases may lead to severe acute pancreatitis. To prevent this development, multimodal management, including nutritional management, is used in treating acute pancreatitis patients. The controversy between parenteral and enteral feeding has led to major debate. This case report aims to assess which method has better outcomes based on multiple cases of organ failure, inflammatory response, and length of hospital stay.

METHODS:

A 46-year-old male presented to the Emergency Department of our hospital with acute abdominal pain, nausea, and vomiting, 12 h before admission. Based on physical and further examination, the patient was diagnosed with severe acute pancreatitis and underwent a necrotomy procedure. Articles from multiple databases were obtained and assessed using the Cochrane Collaboration Risk of Bias tool. The articles were analyzed using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and a forest plot model. Effect size quantification for continuous and categorical variables was analyzed using continuous and binary random effect models, respectively.

RESULTS:

Seven articles were obtained after exclusion and review. A total of 491 patients with acute/severe acute pancreatitis were assessed. These seven articles conclude that enteral nutrition has advantages over parenteral nutrition.

CONCLUSION:

Our study concluded that early enteral feeding provides better clinical improvement, reduced lipase enzyme levels, and shortened length of hospital stay.

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