Safety Observation on Human Embryonic Stem Cell (hESC) Derived Mesenchymal Stem Cells(MSC) Like Cell for the Meniscus Injury

Tongji Hospital1 site in 1 country18 target enrollmentJanuary 4, 2019

ConditionsMeniscus Injury

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Meniscus Injury
Sponsor: Tongji Hospital
Enrollment: 18
Locations: 1
Primary Endpoint: The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury, and observe the safety of the cells for meniscus injury

Detailed Description

Three different dosage of human embryonic stem cell derived mesenchymal stem cells like for meniscus injury patients, and observe the safety of the cells for meniscus injury.

Registry

clinicaltrials.gov

Start Date

January 4, 2019

End Date

September 30, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tongji Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Grade Ⅰ-Ⅱ meniscus injury of knee joint
•The patients who still have the pain of knee joint and/or limitation of the function after accepted 3 months of nonoperative treatment

Exclusion Criteria

•Recent history of lower limb fractures or intra-articular drug injection
•The patients who have meniscus injury of knee joint need the surgical repair
•The patients who have the severe coagulation disorders, cardiopulmonary failure and so on
•The women who are pregnant or nursing
•There are electronic implants such as pacemakers in the body
•The patients who are infected the HIV, the virus of hepatitis or syphilis
•The patients who are alcoholism or drug user
•The patients who have vestibular and balance disorders
•The patients with severe cognitive impairment who cannot follow instructions to complete the treatment
•The patients who don't sign the informed consent

Outcomes

Primary Outcomes

The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events

Time Frame: 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell

Adverse events include：allergic reactions, local reactions or infections at the injection site and muscle or skeletal dysplasia

Secondary Outcomes

Range of knee motion(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
Lysholm Knee Scale(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
MRI of knee(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
Global posture analysis system(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
Dynamic balance test(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
Ultrasound of knee joint(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
Visual Analog Score for pain（VAS）(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)