Safety Observation on hESC Derived MSC Like Cell for the Meniscus Injury

Tongji Hospital18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Meniscus Injury

Interventions

hESC derived MSC like cellBIOLOGICAL

Different dosage of hESC derived MSC like cell for the meniscus injured patients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 * The patients who have tumor * Immunodeficiency patients * The patients who have congenital or acquired knee malformation * Patients or researchers who are participating in other clinical trials believe that other reasons are not appropriate for clinical trials

Locations (1)

Tongji Hospital, Tongji Medical College of Science and Technology

Wuhan, Hubei, China

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

Ultrasound of knee joint

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

Visual Analog Score for pain（VAS）

VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective pain. The scale range is from 0 to 10, the higher the score, the more severe the pain.

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

Range of knee motion

to use the goniometer to measure the range of knee motion

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

Lysholm Knee Scale

The scale is to assess the function of knee. The scale range is from 0 to 100, the higher the score, the more severe the knee problems. This scale includes 8 items, and the total score is the sum of these 8 items' scores. Individual items are scored differently, using individual scoring scales: 1. limp (0,3,5), 2. support (0,2,5), 3. locking (0,2,6,10,15), 4. instability (0,5,10,15,20,25), 5. pain (0,5,10,15,20,25), 6. swelling (0,2,6,10), 7. stair climbing (0,2,6,10), 8. squatting (0,2,4,5).

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

MRI of knee

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.