Mesenchymal Stem Cells for The Treatment of Frailty Syndrome

NCT04914403 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: UMC119-06-05-FS-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. UMC119-06-05 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of frailty syndrome.

Conditions

Frailty Syndrome

Keywords

frailty syndrome

Outcome Measures

Primary Outcomes (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).

  3 months from the day of administration

Secondary Outcomes (6)

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

  From baseline up to 360 days after administration.

• Changes in grip strength.

  From baseline up to 360 days after administration.

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

  From baseline up to 360 days after administration.

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

  From baseline up to 360 days after administration.

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

  From baseline up to 360 days after administration.

Study Arms (1)

UMC119-06-05

EXPERIMENTAL

Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.

Biological: UMC119-06-05

Interventions

UMC119-06-05 BIOLOGICAL

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

UMC119-06-05

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Meridigen Biotech Co., Ltd.: lead

Study Sites (1)

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

New Taipei City, 23561, Taiwan

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Claire Liao, MS

CONTACT

+886-2-8978-7777; claire.liao@meridigen.com

Joseph Chen, MS

CONTACT

+886-2-8978-7777; joseph.chen@meridigen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort 1: Low dose of UMC119-06-05 Cohort 1: High dose of UMC119-06-05

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: December 4, 2023

Record last verified: 2022-12

Locations

TW (1)