Status:
COMPLETED
Clinical Study of Umbilical Cord Mesenchymal Stem Cells Infusion for Aging Frailty
Lead Sponsor:
Shanghai East Hospital
Conditions:
Aging Frailty
Eligibility:
All Genders
60-80 years
Phase:
PHASE1
PHASE2
Brief 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 f...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04314011
Start Date
June 1 2020
End Date
March 1 2022
Last Update
March 17 2022
Active Locations (1)
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1
Shanghai East Hospital, Shanghai Tongji University
Shanghai, China, 200120