Mesenchymal Stem Cells for Frailty Syndrome

NCT06501066 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: UMC119-06-05-FS-12
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Pathologic Processes

Keywords

Frailty; aging; mesenchymal stem cells

Outcome Measures

Primary Outcomes (6)

• 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.

  Up to 12 months through study

• 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.

  Up to 12 months through study

• vital signs

  Phase I: change in vital signs

  Up to 12 months through study

• physical examination

  Phase I: change in physical examination

  Up to 12 months through study

• clinical laboratory test results

  Phase I: change in clinical laboratory test results

  Up to 12 months through study

• electrocardiogram

  Phase I: change in electrocardiogram

  Up to 12 months through study

Secondary Outcomes (5)

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

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

• Mean change from baseline in grip strength

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

• Mean change from baseline in chair-stand test

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

• Mean change from baseline in muscle mass and bone density

  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

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

Study Arms (3)

Phase I Treatment Arm

EXPERIMENTAL

umbilical cord mesenchymal stem cells, 100×10\^6 cells/subject, single treatment by intravenous infusion in phase I.

Biological: umbilical cord mesenchymal stem cells

Phase II Treatment Arm

EXPERIMENTAL

umbilical cord mesenchymal stem cells, 100×10\^6 cells/subject, single treatment by intravenous infusion in phase II.

Biological: umbilical cord mesenchymal stem cells

Phase II Placebo Arm

PLACEBO COMPARATOR

Peripheral IV infusion of placebo at baseline.

Biological: umbilical cord mesenchymal stem cells

Interventions

umbilical cord mesenchymal stem cells BIOLOGICAL

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

Phase I Treatment Arm; Phase II Placebo Arm; Phase II Treatment Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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).

Sponsors & Collaborators

• Meribank Biotech Co., Ltd.: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, 100229, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Pathologic Processes; Frailty

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 15, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

TW (2)