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
Sponsored by
About this trial
This is an interventional treatment trial for Meniscus Injury
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
- 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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Title
Visual Analog Score for pain(VAS)
Description
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
Title
Range of knee motion
Description
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
Title
Lysholm Knee Scale
Description
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
Title
MRI of knee
Description
MRI of knee
Time Frame
baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Title
Global posture analysis system
Description
to test the static balance
Time Frame
baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Title
Dynamic balance test
Description
Use the dynamic posture evaluator
Time Frame
baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Chen, Doctor
Organizational Affiliation
Wuhan TongJi Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Learn more about this trial
Safety Observation on hESC Derived MSC Like Cell for the Meniscus Injury
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