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

Phase 1

• Conditions: Meniscus Injury
• Interventions: Biological: hESC derived MSC like cell

• Registration Number: NCT03839238
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-28
• Study Start: 2019-01-04
• Study First Submitted QC: 2019-02-10
• Last Update Submitted: 2019-02-10
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15
• Primary Completion: 2020-06-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meniscus Injured patients	hESC derived MSC like cell	hESC Derived MSC Like Cell

Primary Outcome Measures

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

Name	Time	Method
Ultrasound of knee joint	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell	Ultrasound of knee joint
Visual Analog Score for pain（VAS）	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell	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.
Range of knee motion	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell	to use the goniometer to measure the range of knee motion
Lysholm Knee Scale	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell	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).
MRI of knee	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell	MRI of knee
Global posture analysis system	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell	to test the static balance
Dynamic balance test	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell	Use the dynamic posture evaluator

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College of Science and Technology; 🇨🇳 Wuhan, Hubei, China