Clinical Study of Umbilical Cord Mesenchymal Stem Cells Infusion for Aging Frailty

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    30
  • sponsor
    Shanghai East Hospital
Updated on 14 March 2021

Summary

The purpose of this clinical study is to answer the questions:

  1. Is the proposed intervention safe?
  2. Is the proposed intervention effective in improving the healthy status of subjects with aging frailty?

Description

Aging frailty is a clinical syndrome, characterized by a decrease of homeostatic reserves and enhanced vulnerability to endogenous or exogenous stressors, exposing individuals to an increased risk of adverse health-related outcomes. The human umbilical cord (HUC) is a promising source of mesenchymal stem cells (MSCs), compared to embryonic stem cells, HUC-MSCs are noncontroversial with a painless collection procedure and faster self-renewal properties. HUC-MSCs can differentiate into the different germ layers and modulate immune responses. One possible mechanism for the onset and development of aging frailty is the depletion of stem cells. Hence, intravenous infusion of HUC-MSCs is attractive therapy against aging frailty.

This is a randomized, double-blind, placebo-controlled clinical trial. The participants from two centers (n = 30) will be randomly distributed into two groups. The HUC-MSCs Group (n = 15) will receive intravenous infusion of mesenchymal stem cells twice over a month (30 days interval), the Control Group (n = 15) will receive the same protocolized intervention with normal saline. Follow-up duration is 6 months after first intervention. The reported serious adverse eventsSAEswill be observed within one month post infusion. The short-item from health surveySF-36), EuroQol five dimensions questionnaire (EQ-5D) and Fried phenotype scale will be evaluated. Short physical performance battery (SPPB) and plasm biomarkers will be assessed.The assessments will be performed at baseline, 1 month, 3 months and 6 months.

The intent of this study is to explore domains of efficacy of HUC-MSCs through the reduction of signs and symptoms of aging frailty and to evaluate the safety of HUC-MSCs in subjects with aging frailty.

Details
Condition Aging Frailty
Treatment Placebo, Human umbilical cord mesenchymal stem cells(HUC-MSCs)
Clinical Study IdentifierNCT04314011
SponsorShanghai East Hospital
Last Modified on14 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects age 60 and 80 years at the time of signing the informed consent form
Must show signs of frailty apart from a concomitant condition as assessed by the investigator with a frailty score of 1 to 4 using the Fried Phenotype Scale
Must provide written informed consent
Subjects are expected to live more than 12 months

Exclusion Criteria

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
Advanced liver or renal failure, class III/IV congestive heart failure, myocardial infarction, unstable angina, cardiac revascularization, or severe obstructive ventilator defect
Uncontrolled hypertension or hyperglycemia
Have known allergies to biological drugs or antibiotics
Expecting to receive organ transplantation
Have a clinical history of malignancy or active autoimmune diseases
Have a history of drug or alcohol abuse within the past 24 months
Be serum-positive for HIV, hepatitis BsAg or viremic hepatitis C
Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial
Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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