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

February 10, 2019 updated by: Tongji Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ultrasound of knee joint
Time Frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
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）
Time Frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
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
Time Frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
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
Time Frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
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
Time Frame: 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
Global posture analysis system
Time Frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
to test the static balance
baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Dynamic balance test
Time Frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Use the dynamic posture evaluator
baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese Academy of Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hong Chen, Doctor, Wuhan TongJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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