Using stem cells to treat frailty syndrome in older adults

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.

This study is testing a new stem cell treatment to see if it can help older adults aged 60 to 85 who are experiencing frailty feel better and improve their health.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: Meridigen Biotech Co., Ltd. (industry)
• Drugs / interventions: prednisone
• Locations: 1 site (New Taipei City)
• Trial ID: NCT04914403 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety of UMC119-06-05, an ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cell product, in treating frailty syndrome among older adults. It is a dose escalation, open label, single-center study targeting adults aged 60 to 85 who exhibit signs of frailty. The study aims to address the unmet clinical need for effective interventions for frailty syndrome, which is characterized by a decline in health and increased risk of poor outcomes. Participants will be assessed for eligibility based on specific frailty criteria and will provide informed consent before participation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 60 to 85 who exhibit signs of frailty as assessed by a Clinical Frailty scale.

Not a fit: Patients with significant neurological disorders or severe comorbid medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the health outcomes and quality of life for older adults suffering from frailty syndrome.

How similar studies have performed: While there have been various approaches to treating frailty, the use of mesenchymal stem cells is relatively novel and has not been extensively tested in this context.

Eligibility criteria

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.

Where this trial is running

New Taipei City

• Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare. — New Taipei City, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Claire Liao, MS

Conditions: Frailty Syndrome, frailty syndrome