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

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

human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury, and observe the safety of the cells for meniscus injury

Study Overview

• Status: Unknown
• Conditions: Meniscus Injury
• Intervention / Treatment: Biological: hESC derived MSC like cell

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 Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meniscus Injured patients; hESC Derived MSC Like Cell	Biological: hESC derived MSC like cell; Different dosage of hESC derived MSC like cell for the meniscus injured patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound of knee joint	Ultrasound of knee joint	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
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
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
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
MRI of knee	MRI of knee	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
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
Dynamic balance test	Use the dynamic posture evaluator	baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Chinese Academy of Sciences
• Investigators: Study Director: Hong Chen, Doctor, Wuhan Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: February 10, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Wuhan Tongji Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No