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

Primary Purpose

Meniscus Injury

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

hESC derived MSC like cell

About this trial

This is an interventional treatment trial for Meniscus Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tongji Hospital, Tongji Medical College of Science and Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meniscus Injured patients

Arm Description

hESC Derived MSC Like Cell

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ultrasound of knee joint

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.

Range of knee motion

to use the goniometer to measure the range of knee motion

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).

MRI of knee

Global posture analysis system

to test the static balance

Dynamic balance test

Use the dynamic posture evaluator

Full Information

NCT ID

NCT03839238

First Posted

November 28, 2018

Last Updated

February 10, 2019

Sponsor

Tongji Hospital

Collaborators

Chinese Academy of Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03839238

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 4, 2019 (Actual)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tongji Hospital

Collaborators

Chinese Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meniscus Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Meniscus Injured patients

Arm Type

Experimental

Arm Description

hESC Derived MSC Like Cell

Intervention Type

Biological

Intervention Name(s)

hESC derived MSC like cell

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Ultrasound of knee joint

Description

Ultrasound of knee joint

Time Frame