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Pathologic ProcessesPhase 1/2NCT06501066

Mesenchymal Stem Cells for Frailty Syndrome

A Phase 1/2 study testing umbilical cord mesenchymal stem cells in people with Pathologic Processes, run by Meribank Biotech Co., Ltd. at 2 sites in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Pathologic Processes
What is being tested?
umbilical cord mesenchymal stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
2 sitesTaiwan
Study dates
3 Jun 2024to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Subjects will be eligible for enrollment in the study only if they meet ALL of the following criteria:
  • Subjects of age ≥ 65 years old at screening.
  • Subjects show signs of frailty as assessed by CHS frailty Scores ≥ 1 at screening.
  • Subjects with body weight between 40 kg to 90 kg.
  • Subjects have received standard of care treatment (including exercise and nutritional supplementation) for FS for at least 30 days prior to the study.
  • 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 will be eligible for enrollment in the study only if they meet NONE of the following criteria:
  • Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.
  • Subjects who have a significant comorbid medical condition(s), as judged by the investigator, including, but not limited to:
  • 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;
  • 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 (New York Heart Association [NYHA] class 3 and 4);
  • Autoimmune disease (rheumatoid arthritis, psoriasis/psoriatic arthritis, multiple sclerosis, systemic lupus erythematosus, etc.);
  • Hearing or visual impairment that significantly impact the assessments for endpoint analysis;
  • Pulmonary dysfunction requiring steroid therapy or O2 supplementation
  • Uncontrolled metabolic diseases including type II diabetes mellitus (hemoglobin A1c [HbA1c] > 8.5%)
  • 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.
  • Subjects using chronic high dose of steroid (> 5 mg prednisolone or equivalent), immunosuppressant therapy, or TNF-α antagonists.
  • Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections.
  • Subjects with known allergy or hypersensitivity to any component of the formulation (normal saline, human serum albumin, or dimethyl sulfoxide).
  • Subjects who have participated in another clinical study of new investigational therapies within 3 months before the study drug administration.
  • Subjects who have received any other stem cell therapy within 12 months before the study drug administration.
  • 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.
  • Subjects who have any hospitalization record within one month before the study drug administration (except for the scheduled admission in this study, if required).
  • 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.
  • 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.

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 100229

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
umbilical cord mesenchymal stem cells
Keywords
Frailty, aging, mesenchymal stem cells
Medical subject headings
Pathologic Processes, Frailty

What participants receive

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

  • umbilical cord mesenchymal stem cellsBiological

    Patients assigned to UC-MSC administration groups will receive one administrations

Study groups in NCT06501066
Study groupRoleWhat they receive
Phase I Treatment ArmExperimentalumbilical cord mesenchymal stem cells, 100×10^6 cells/subject, single treatment by intravenous infusion in phase I.
Receives: Biological: umbilical cord mesenchymal stem cells
Phase II Treatment ArmExperimentalumbilical cord mesenchymal stem cells, 100×10^6 cells/subject, single treatment by intravenous infusion in phase II.
Receives: Biological: umbilical cord mesenchymal stem cells
Phase II Placebo ArmPlacebo comparatorPeripheral IV infusion of placebo at baseline.
Receives: Biological: umbilical cord mesenchymal stem cells

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)/ Serious Adverse Events (SAEs).

    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.

    Measured: Up to 12 months through study

  2. Incidence of withdrawals due to adverse events

    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.

    Measured: Up to 12 months through study

  3. vital signs

    Phase I: change in vital signs

    Measured: Up to 12 months through study

  4. physical examination

    Phase I: change in physical examination

    Measured: Up to 12 months through study

  5. clinical laboratory test results

    Phase I: change in clinical laboratory test results

    Measured: Up to 12 months through study

  6. electrocardiogram

    Phase I: change in electrocardiogram

    Measured: Up to 12 months through study

Secondary outcomes (5)

  1. Mean change from baseline in frailty status (Cardiovascular Health Study [CHS] frailty score

    CHS scale consists of five components-unintentional weight loss, exhaustion, low activity, weakness, and slowness

    Measured: change from baseline to Day 91, Day 181, and Day 361

  2. Mean change from baseline in grip strength

    Hand grip strength as assessed by a dynamometer. Grip strength is recorded (in mmHg) three times for each hand.

    Measured: change from baseline to Day 91, Day 181, and Day 361

  3. Mean change from baseline in chair-stand test

    a subject is able to transfer from a seated to a standing position and back to sitting five times

    Measured: change from baseline to Day 91, Day 181, and Day 361

  4. Mean change from baseline in muscle mass and bone density

    muscle mass and bone density will be measured using DXA

    Measured: change from baseline to Day 91, Day 181, and Day 361

  5. Mean change from baseline in quality of life measured by change in SF-12

    a quality of life measure

    Measured: change from baseline to Day 91, Day 181, and Day 361

Timeline

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

  1. First posted15 Jul 2024
  2. Study start3 Jun 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06501066
Sponsor's protocol ID
UMC119-06-05-FS-12
Status last verified
Jul 2024
First submitted
18 Jun 2024
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing umbilical cord mesenchymal stem cells in people with Pathologic Processes, run by Meribank Biotech Co., Ltd. at 2 sites 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 6 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (TEAEs)/ Serious Adverse Events (SAEs). (time frame: Up to 12 months through study). The study lists 6 primary outcomes in all. 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 NCT06501066.

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 15 Jul 2024.

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