NCT04314011

Brief Summary

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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

December 10, 2019

Last Update Submit

March 2, 2022

Conditions

Aging Frailty

Outcome Measures

Primary Outcomes (1)

  • Safety of HUC-MSCs infusion

    Safety were assessed by incidence of reported serious adverse events (SAEs) within one month after infusion. An SAE is defined as any untoward medical occurrence that: 1. Results in death 2. Is life-threatening (stroke or non-fatal pulmonary embolism, etc.) 3. Requires inpatients hospitalization or prolongation of hospitalization 4. Results in clinically significant abnormal laboratory test results or abnormal vital signs, based on clinical judgment.

    Within one month post infusion

Secondary Outcomes (4)

  • Difference in rate of decline of Frailty

    Baseline, month 1, 3 month and 6 months post infusion

  • Difference in subject quality of life assessments

    Baseline, month 1, month 3 and month 6 post infusion

  • Changes in the pro-inflammatory cytokines of blood sample between the HUC-MSC and placebo cohorts

    Baseline, month 1, month 3 and month 6 post infusion

  • Changes in cellular components of the immune system between the HUC-MSC and placebo cohorts

    Baseline, month 1, month 3 and month 6 post infusion

Study Arms (2)

HUC-MSCs Group

EXPERIMENTAL

Human umbilical cord mesenchymal stem cells (1\*10\^6/kg cells): delivered via peripheral intravenous infusion.

Biological: Human umbilical cord mesenchymal stem cells（HUC-MSCs）

Control Group

PLACEBO COMPARATOR

Placebo:normal saline delivered via peripheral intravenous infusion.

Biological: Placebo

Interventions

Human umbilical cord mesenchymal stem cells（HUC-MSCs）BIOLOGICAL

Human umbilical cord mesenchymal stem cells（HUC-MSCs）

HUC-MSCs Group
PlaceboBIOLOGICAL

Placebo

Control Group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital, Shanghai Tongji University

Shanghai, 200120, China

Location

Related Publications (1)

  • Zhu Y, Huang C, Zheng L, Li Q, Ge J, Geng S, Zhai M, Chen X, Yuan H, Li Y, Jia W, Sun K, Li Y, Ye T, Zhao Z, Liu H, Liu Z, Jiang H. Safety and efficacy of umbilical cord tissue-derived mesenchymal stem cells in the treatment of patients with aging frailty: a phase I/II randomized, double-blind, placebo-controlled study. Stem Cell Res Ther. 2024 Apr 29;15(1):122. doi: 10.1186/s13287-024-03707-2.

    PMID: 38679727DERIVED

Study Officials

  • Zhongming Liu, MD/Ph.D

    Shanghai East Hospital, Shanghai Tongji University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2019

First Posted

March 18, 2020

Study Start

June 1, 2020

Primary Completion

December 30, 2021

Study Completion

March 1, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Locations

CN(1)