Clinical trial NCT03839238: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Meniscus Injury
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2019-02-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events
timeFrame: 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Secondary outcomes:
measure: Ultrasound of knee joint
timeFrame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
measure: Visual Analog Score for pain（VAS）
timeFrame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
measure: Range of knee motion
timeFrame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
measure: Lysholm Knee Scale
timeFrame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
measure: MRI of knee
timeFrame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
measure: Global posture analysis system
timeFrame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
measure: Dynamic balance test
timeFrame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan TongJi Hospital
name: Hong Chen, Doctor
role: STUDY_DIRECTOR
References: