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

NCT03839238 | Unknown Phase 1 DMC

• 1 other identifier: Wuhan Tongji Hospital
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Meniscus Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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）

  baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell

• Range of knee motion

  baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell

• Lysholm Knee Scale

  baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell

• MRI of knee

  baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell

Study Arms (1)

Meniscus Injured patients

EXPERIMENTAL

hESC Derived MSC Like Cell

Biological: hESC derived MSC like cell

Interventions

hESC derived MSC like cell BIOLOGICAL

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

Meniscus Injured patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead
• Chinese Academy of Sciences: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Officials

• Hong Chen, Doctor

  Wuhan TongJi Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: February 15, 2019
• Study Start: January 4, 2019
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 15, 2019

Record last verified: 2018-11

Locations

CN (1)