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Frailty SyndromePhase 1NCT04914403

Mesenchymal Stem Cells for The Treatment of Frailty Syndrome

A Phase 1 study testing UMC119-06-05 in people with Frailty Syndrome, run by Meridigen Biotech Co., Ltd. at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The clinical study with UMC119-06-05 is designed to investigate the safety in patients with frailty syndrome. This will be a dose escalation, open label, single-center study in adult with frailty syndrome. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Frailty Syndrome
What is being tested?
UMC119-06-05
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteTaiwan
Study dates
1 Sep 2021to Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects of age between ≥ 60 through ≤ 85 years.
  • Subjects show signs of frailty condition as assessed by the Investigator with a Clinical Frailty scale between 4 to 6.
  • Subjects with body weight between 40 to 90 kg.
  • Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.

Who cannot join

  • Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.
  • Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis or dementia.
  • Subjects have a score on the Mini-Mental State Examination (MMSE) of 24 or below, or have been unstable on neurological examination within the past 6 months.
  • Subjects who have a significant comorbid medical condition(s) including, but not limited to:
  • Severe kidney disease requiring hemodialysis or peritoneal dialysis;
  • Advanced liver disease such as hepatitis or liver cirrhosis;
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  • Severe congestive heart failure (NYHA class 3 and 4);
  • Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease stage III or IV (Gold classification)
  • Hypothyroidism (TSH > 10 mU/L) or hyperthyroidism (TSH < 0.1 mU/L)
  • Subjects on chronic immunosuppressive transplant therapy.
  • Subjects who have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma or in situ carcinomas.
  • Subjects using chronic immunosuppressant therapy (including prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) or TNF-alpha antagonists.
  • Subjects who are known to be infected with HIV.
  • Subjects with known allergy or hypersensitivity to any component of the formulation, including normal saline, human serum albumin, dimethyl sulfoxide (DMSO) and cellular therapies.
  • Subjects who have participated in another clinical study of new investigational therapies within 6 months before the study drug administration.
  • Subjects have a history of drug or alcohol abuse within the past 3 years.
  • Subjects currently in hospital stay.
  • Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
  • Subjects with uncorrected hematology test including, but not limited to:
  • Hemoglobin < 8 g/dl
  • White blood cell count < 3,000/mm3
  • International normalized ratio (INR) of Coagulopathy >1.5
  • Platelet count < 80,000/mm3
  • Subjects who have the following conditions in laboratory tests:
  • >2 × upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
  • Total bilirubin > 1.5 mg/dl
  • Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to:
  • Psychiatric illness
  • Uncontrolled hypertension or hypotension (specify numeric cutoffs)
  • Unstable cardiac arrhythmia
  • Severe osteoarthritis or degenerative joint disease
  • Hepatitis B, Hepatitis C infections
  • History of COVID-19 in the past 4 weeks or with significant COVID-19 conditions judged by PI, or ongoing COVID-19
  • Have any condition that in the opinion of the Principal Investigator limits lifespan to < 1 year.

Trial locations and contacts

1 site in 1 country.

Claire Liao, MS contact

+886-2-8978-7777 ext. 19965

claire.liao@meridigen.com

Joseph Chen, MS contact

+886-2-8978-7777 ext. 19905

joseph.chen@meridigen.com

Taiwan1 site, 1 recruiting

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.

    New Taipei City, 23561

    Claire Liao, MS, +886-2-8978-7777 ext. 19965, Claire.Liao@meridigen.com

    Joseph Chen, MS, +886-2-8978-7777 ext. 19905, joseph.chen@meridigen.com

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase I, Open Label, Dose Escalation Study to Evaluate the Safety and Tolerability After Intravenous Infusion of UMC119-06-05 in Elderly Subjects With Mild to Moderate Frailty Syndrome.

The clinical study with UMC119-06-05 is designed to investigate the safety in patients with frailty syndrome. This will be a dose escalation, open label, single-center study in adult with frailty syndrome. UMC119-06-05 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of frailty syndrome.

Read the detailed description

Frailty syndrome is the most problematic expression of population ageing and profound implications for the planning and delivery of health and social care when population ageing is accelerating rapidly worldwide, from 461 million people older than 65 years in 2004 to an estimated 2 billion people by 2050 . Frailty syndrome characterized by a progressive decline in health and clinical symptoms of exhaustion, weight loss, a feeling of slowing down, and a decrease in functional capacity. Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality. Health study as meeting three out of five phenotypic criteria: low grip strength, self-reported exhaustion, slowed walking speed, low physical activity, and unintentional weight loss. Frailty is a disorder of several inter-related physiological systems, including genetic and environmental factors in combination with epigenetic mechanisms, which regulate the differential expression of genes in cells and could be especially important in ageing. Current interventions focus on interdisciplinary approaches which include nutritional supplementation, physical exercise, and cognitive intervention. Clinical studies of these preventative approaches have shown inconsistent and modest benefits, further highlighting the unmet clinical need. Therefore, development of new therapeutic modalities to improve the clinical outcomes and prognosis of frailty syndrome in adult patients is of urgent need. A variety of pharmacologic and biologic therapies are currently being tested to treat aging. Among the more innovative, experimental therapies, Mesenchymal Stromal Cells (MSCs) are represents an attractive option that addresses the pathophysiology of the syndrome.

Being tested
UMC119-06-05
Keywords
frailty syndrome
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UMC119-06-05Biological

    Cohort 1: Low does of UMC119-06-05 Cohort 2: High does of UMC119-06-05

Study groups in NCT04914403
Study groupRoleWhat they receive
UMC119-06-05ExperimentalHuman Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.
Receives: Biological: UMC119-06-05

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence and frequency of adverse events related to administration of UMC119-06-05.

    Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to Adverse Events(AEs).

    Measured: 3 months from the day of administration

Secondary outcomes (6)

  1. Changes in exercise performance using 6-min walk test (6MWT).

    The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test. Improvement in clinical function as assessed by mean change in exercise performance using 6-min walk test (6MWT).

    Measured: From baseline up to 360 days after administration.

  2. Changes in grip strength.

    Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. The force has most commonly been measured in kilograms.

    Measured: From baseline up to 360 days after administration.

  3. Changes in quality of life measured by change in SF12 (12-Item Short Form).

    The 12-Item Short Form Health Survey (SF-12) is a 12-item measure of perceived health status with good reliability, validity and correlation with other health measures. The score is computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.

    Measured: From baseline up to 360 days after administration.

  4. Changes in physical activity using International Physical Activity Questionnaire (IPAQ) questionnaire

    The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. Categorical score to three levels of physical activity are Low, or Moderate, or High.

    Measured: From baseline up to 360 days after administration.

  5. Changes in Forced Expiratory Volume in One Second (FEV1).

    Improvement in clinical function as assessed by mean change in One Second to the Forced Vital Capacity.

    Measured: From baseline up to 360 days after administration.

  6. Changes in Clinical Frailty Scale.

    Clinical Frailty Scale evaluates specific domains, including comorbidity, function, and cognition, to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).

    Measured: From baseline up to 360 days after administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start1 Sep 2021
  3. Primary completionDec 2024 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Cohort 1: Low dose of UMC119-06-05 Cohort 1: High dose of UMC119-06-05
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04914403
Sponsor's protocol ID
UMC119-06-05-FS-01
Status last verified
Dec 2022
First submitted
31 May 2021
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UMC119-06-05 in people with Frailty Syndrome, run by Meridigen Biotech Co., Ltd. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Claire Liao, MS (+886-2-8978-7777 ext. 19965, claire.liao@meridigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and frequency of adverse events related to administration of UMC119-06-05. (time frame: 3 months from the day of administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04914403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.

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