Mesenchymal Stem/Stromal Cell Therapy in the Treatment of Frailty

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) in combination with standard frailty treatment in Vietnam

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

Criteria

Inclusion Criteria:

• Must show signs of frailty apart from a concomitant condition as assessed by the investigator with a frailty score >=3 using the Fried Phenotype Scale.

• They showed the signs of frailty based on physician assessment, apart from a concomitant condition, by a score between 3 and 6 as denoted by the Canadian Study on Health Aging.

• Must provide written informed consent.

Exclusion Criteria:

• Score of less than or equal to 20 on the Mini-Mental State Examination (MMSE)

• Active listing (or expected future listing) for transplant of any organ.

• Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin <8 g/dl, white blood cell count <3000/mm3, platelets<80,000/mm3, alkaline phosphatase > 3 times the upper limit of normal, total bilirubin > 1.5 mg/dl.

• Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to HIV, advanced liver or renal failure, class II/III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilator defect, COPD with GOLD D, ischemic stroke with NIHSS <5, type II diabetes with HbA1C >8.5%

• 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.

• Be an organ transplant recipient.

• 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, squamous cell carcinoma, melanoma in situ or cervical carcinoma if recurrence occurs.

• Have a non-pulmonary condition that limits lifespan to < 1 year.