Mesenchymal Stem Cells for The Treatment of Frailty Syndrome

December 1, 2023 updated by: Meridigen Biotech Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
        • Principal Investigator:
          • Shih-Wei Huang, M.D., Ph. D.
        • Sub-Investigator:
          • Tsan-Hon Liou, M.D., Ph. D.
        • Sub-Investigator:
          • Hung-Chou Chen, M.D.
        • Sub-Investigator:
          • Lung Chan, M.D., Ph. D.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

    1. Severe kidney disease requiring hemodialysis or peritoneal dialysis;
    2. Advanced liver disease such as hepatitis or liver cirrhosis;
    3. Severe congestive heart failure (NYHA class 3 and 4);
    4. Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease stage III or IV (Gold classification)
    5. 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:

    1. Hemoglobin < 8 g/dl
    2. White blood cell count < 3,000/mm3
    3. International normalized ratio (INR) of Coagulopathy >1.5
    4. Platelet count < 80,000/mm3

  • Subjects who have the following conditions in laboratory tests:

    1. >2 × upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
    2. Total bilirubin > 1.5 mg/dl

  • Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to:

    1. Psychiatric illness
    2. Uncontrolled hypertension or hypotension (specify numeric cutoffs)
    3. Unstable cardiac arrhythmia
    4. Severe osteoarthritis or degenerative joint disease
    5. Hepatitis B, Hepatitis C infections
    6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: UMC119-06-05
Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.
Biological: UMC119-06-05
Cohort 1: Low does of UMC119-06-05 Cohort 2: High does of UMC119-06-05

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence and frequency of adverse events related to administration of UMC119-06-05.
Time Frame: 3 months from the day of administration
Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to Adverse Events(AEs).
3 months from the day of administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in exercise performance using 6-min walk test (6MWT).
Time Frame: From baseline up to 360 days after administration.
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).
From baseline up to 360 days after administration.
Changes in grip strength.
Time Frame: From baseline up to 360 days after administration.
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.
From baseline up to 360 days after administration.
Changes in quality of life measured by change in SF12 (12-Item Short Form).
Time Frame: From baseline up to 360 days after administration.
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.
From baseline up to 360 days after administration.
Changes in physical activity using International Physical Activity Questionnaire (IPAQ) questionnaire
Time Frame: From baseline up to 360 days after administration.
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.
From baseline up to 360 days after administration.
Changes in Forced Expiratory Volume in One Second (FEV1).
Time Frame: From baseline up to 360 days after administration.
Improvement in clinical function as assessed by mean change in One Second to the Forced Vital Capacity.
From baseline up to 360 days after administration.
Changes in Clinical Frailty Scale.
Time Frame: From baseline up to 360 days after administration.
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).
From baseline up to 360 days after administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meridigen Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMC119-06-05-FS-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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