Mesenchymal Stem Cells for Frailty Syndrome

July 11, 2024 updated by: Meribank Biotech Co., Ltd.

A Two-part, Phase I/II, Randomized, Single-blind Study to Evaluate the Efficacy and Safety of UMC119-06-05 in Older Adults With Pre-frailty & Frailty

This Phase I/II study is designed to evaluate the efficacy and safety of UMC119-06-05, an allogeneic umbilical cord mesenchymal stem cells, in older adults with frailty syndrome. This study will also seek to determine the long-term safety and clinical outcomes of UMC119-06-05 in subjects with frailty syndrome, which will provide information for subsequent clinical trials with UMC119-06-05.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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 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. 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. Current interventions focus on interdisciplinary approaches which include nutritional supplementation, physical exercise, and cognitive intervention. The lack of standardized treatment of the disease resulted in the increasing number of elders diagnosed with frailty. Therefore, development of new therapeutic modalities to improve the clinical outcomes and prognosis of frailty syndrome in adult patients is of urgent need. Recently, preclinical and clinical studies support a cell-based, regenerative treatment strategy i.e., allogenic umbilical cord mesenchymal stem cell therapy may represent a novel therapy for aging frailty. This clinical trial is a phase I/II study. Phase I is an open-label study and all eligible subjects will receive a single-dose IV infusion of UMC119-06-05. Phase II study is a randomized, placebo-controlled, single-blind study and half of eligible subjects will receive a single-dose IV infusion of UMC119-06-05, the others will receive placebo.

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 (Actual)

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.
66

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 2
  • 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 Locations

  • Taiwan
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei city, Taiwan, 100229
        • National Taiwan University Hospital

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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects will be eligible for enrollment in the study only if they meet ALL of the following criteria:

  1. Subjects of age ≥ 65 years old at screening.
  2. Subjects show signs of frailty as assessed by CHS frailty Scores ≥ 1 at screening.
  3. Subjects with body weight between 40 kg to 90 kg.
  4. Subjects have received standard of care treatment (including exercise and nutritional supplementation) for FS for at least 30 days prior to the study.
  5. 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 will be eligible for enrollment in the study only if they meet NONE of the following criteria:

  1. Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.

  2. Subjects who have a significant comorbid medical condition(s), as judged by the investigator, including, but not limited to:

    1. Confirmed diagnosis of disabling neurologic disorder, including but not limited to Parkinson's disease, Amyotrophic lateral sclerosis, Stroke, or dementia, that significantly impact the assessments for endpoint analysis;
    2. Severe kidney disease requiring hemodialysis or peritoneal dialysis;
    3. Advanced liver disease such as hepatitis or liver cirrhosis;
    4. Severe congestive heart failure (New York Heart Association [NYHA] class 3 and 4);
    5. Autoimmune disease (rheumatoid arthritis, psoriasis/psoriatic arthritis, multiple sclerosis, systemic lupus erythematosus, etc.);
    6. Hearing or visual impairment that significantly impact the assessments for endpoint analysis;
    7. Pulmonary dysfunction requiring steroid therapy or O2 supplementation
    8. Uncontrolled metabolic diseases including type II diabetes mellitus (hemoglobin A1c [HbA1c] > 8.5%)
  3. Subjects carry history of malignancy of any organ system (other than curatively treated localized basal or squamous cell carcinoma of the skin, cervical carcinoma in situ) within 5 years prior to the screening visit.
  4. Subjects using chronic high dose of steroid (> 5 mg prednisolone or equivalent), immunosuppressant therapy, or TNF-α antagonists.
  5. Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections.
  6. Subjects with known allergy or hypersensitivity to any component of the formulation (normal saline, human serum albumin, or dimethyl sulfoxide).
  7. Subjects who have participated in another clinical study of new investigational therapies within 3 months before the study drug administration.
  8. Subjects who have received any other stem cell therapy within 12 months before the study drug administration.
  9. Subjects have a history of moderate to severe substance use disorder (including alcohol, cannabis, hallucinogens, inhalants, opioids, sedatives/hypnotics/anxiolytics, and stimulants [e.g., amphetamine-type substance, cocaine]) based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) within the past 3 years.
  10. Subjects who have any hospitalization record within one month before the study drug administration (except for the scheduled admission in this study, if required).
  11. Subjects who have dramatic change in their standard of care treatment (including exercise and nutritional supplements) for improvement of frailty within one month prior to study treatment, as judged by the investigator.
  12. 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.

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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

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: Phase I Treatment Arm
umbilical cord mesenchymal stem cells, 100×10^6 cells/subject, single treatment by intravenous infusion in phase I.
Biological: umbilical cord mesenchymal stem cells
Patients assigned to UC-MSC administration groups will receive one administrations
Experimental: Phase II Treatment Arm
umbilical cord mesenchymal stem cells, 100×10^6 cells/subject, single treatment by intravenous infusion in phase II.
Biological: umbilical cord mesenchymal stem cells
Patients assigned to UC-MSC administration groups will receive one administrations
Placebo Comparator: Phase II Placebo Arm
Peripheral IV infusion of placebo at baseline.
Biological: umbilical cord mesenchymal stem cells
Patients assigned to UC-MSC administration groups will receive one administrations

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
Incidence of Treatment-Emergent Adverse Events (TEAEs)/ Serious Adverse Events (SAEs).
Time Frame: Up to 12 months through study
Phase I : Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Up to 12 months through study
Incidence of withdrawals due to adverse events
Time Frame: Up to 12 months through study
Phase I: Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Up to 12 months through study
vital signs
Time Frame: Up to 12 months through study
Phase I: change in vital signs
Up to 12 months through study
physical examination
Time Frame: Up to 12 months through study
Phase I: change in physical examination
Up to 12 months through study
clinical laboratory test results
Time Frame: Up to 12 months through study
Phase I: change in clinical laboratory test results
Up to 12 months through study
electrocardiogram
Time Frame: Up to 12 months through study
Phase I: change in electrocardiogram
Up to 12 months through study

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
Mean change from baseline in frailty status (Cardiovascular Health Study [CHS] frailty score
Time Frame: change from baseline to Day 91, Day 181, and Day 361
CHS scale consists of five components-unintentional weight loss, exhaustion, low activity, weakness, and slowness
change from baseline to Day 91, Day 181, and Day 361
Mean change from baseline in grip strength
Time Frame: change from baseline to Day 91, Day 181, and Day 361
Hand grip strength as assessed by a dynamometer. Grip strength is recorded (in mmHg) three times for each hand.
change from baseline to Day 91, Day 181, and Day 361
Mean change from baseline in chair-stand test
Time Frame: change from baseline to Day 91, Day 181, and Day 361
a subject is able to transfer from a seated to a standing position and back to sitting five times
change from baseline to Day 91, Day 181, and Day 361
Mean change from baseline in muscle mass and bone density
Time Frame: change from baseline to Day 91, Day 181, and Day 361
muscle mass and bone density will be measured using DXA
change from baseline to Day 91, Day 181, and Day 361
Mean change from baseline in quality of life measured by change in SF-12
Time Frame: change from baseline to Day 91, Day 181, and Day 361
a quality of life measure
change from baseline to Day 91, Day 181, and Day 361

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.
Meribank 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.
June 3, 2024

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, 2026

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.
December 1, 2027

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).
June 18, 2024

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.
July 11, 2024

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.
July 15, 2024

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.
July 15, 2024

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.
July 11, 2024

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.
July 1, 2024

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-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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