Mesenchymal Stem/Stromal Cell Therapy in the Treatment of Frailty

Last updated: June 3, 2024
Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

N/A

Treatment

Umbilical Cord Mesenchymal Stem Cells transplantation

standard frailty treatment and supplementary medication

Clinical Study ID

NCT04919135
VinmecISC2111
  • Ages 60-85
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  • Must provide written informed consent.

Exclusion

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 limitedto: 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 > 1.5mg/dl.

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

  • Any other condition that, in the opinion of the investigator, may compromise thesafety 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 priormalignancy must be disease-free for 5 years), except curatively treated basal cellcarcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma ifrecurrence occurs.

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

Study Design

Total Participants: 158
Treatment Group(s): 2
Primary Treatment: Umbilical Cord Mesenchymal Stem Cells transplantation
Phase: 1/2
Study Start date:
October 19, 2021
Estimated Completion Date:
December 30, 2024

Study Description

Frailty, a specific condition of increased vulnerability and reduced general health associated with aging in elderly people, is an emerging global burden requiring major implications for clinical practice and public health. The lack of standardized definition and treatment of the disease resulted in the increasing number of elders diagnosed with frailty. Recently, preclinical and clinical studies support the safety of mesenchymal stem/stromal cells (MSCs) in the treatment of frailty. However, no comprehensive study has been conducted to access the interrelationship between frailty conditions and the effects of MSC-based therapy. To fill this knowledge gap, the aim of the 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. Moreover, this study describes the rationale, study design, methodologies, and analysis strategy currently employed in stem cell research and clinical study. This randomized case-control phase I/II trial is conducted at Vinmec Times City International Hospital, Hanoi, Vietnam between July 2021 and November 2022. In this trial, 44 patients will be enrolled and randomized into a UC-MSC administration group and control group. Both groups will receive the standard frailty treatment and supplementary medication. The UC-MSC group will receive two doses of thawed UC-MSC product at 1.5x10^6 cells/kg of patient body's weight with an intervention interval of three months. The primary outcome measures will include the incidence of prespecified administration-associated adverse events (AEs) and serious adverse events (SAEs). The potential efficacy will be evaluated based on the improvement in frailty conditions (including physical examination, patient-reported outcomes, quality of life, immune markers of frailty, metabolism analysis, and cytokine markers from patient's plasma). The clinical evaluation will be conducted at baseline and 1-, 3-, 6- and 9-months post-intervention. This clinical trial and stem cell analysis associated with patients' sampling at different timepoints seeks to identify and characterize the potential effects of UC-MSCs on the improvement of frailty based on stem cell quality, cytokines/growth factors secretion profiles of UC-MSCs, cellular senescence, and metabolic analysis of patient's CD3+ cells. The ultimate results of the study will be essential for evaluating the utility of UC-MSC therapy for the treatment of frailty and mechanism underlying these effects providing the fundamental knowledge for designing and implementing research strategy of future studies

Connect with a study center

  • Vinmec Research Institute of Stem Cell and Gene Technology

    Hanoi, 100000
    Vietnam

    Site Not Available

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