NCT04314011

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of Umbilical Cord Mesenchymal Stem Cells Infusion for Aging Frailty

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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?

Detailed 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 (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 events（SAEs）will be observed within one month post infusion. The short-item from health survey（SF-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.

Conditions

• Aging Frailty

Interventions

Type	Name	Description
BIOLOGICAL	Human umbilical cord mesenchymal stem cells（HUC-MSCs）	Human umbilical cord mesenchymal stem cells（HUC-MSCs）
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-12-30
• Completion: 2022-03-01
• First posted: 2020-03-18
• Last updated: 2022-03-17

Locations

1 site across 1 country: China