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

Meniscus Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03839238
• Other study ID #: Wuhan Tongji Hospital
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 4, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2018
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Grade ?-? 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

Related Conditions & MeSH terms

• Meniscus Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Tongji Hospital	Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Secondary	Ultrasound of knee joint	Ultrasound of knee joint	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Secondary	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.	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Secondary	Range of knee motion	to use the goniometer to measure the range of knee motion	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Secondary	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).	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Secondary	MRI of knee	MRI of knee	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Secondary	Global posture analysis system	to test the static balance	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Secondary	Dynamic balance test	Use the dynamic posture evaluator	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell