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

NCT ID: NCT03839238

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-04

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Meniscus Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meniscus Injured patients

hESC Derived MSC Like Cell

Group Type EXPERIMENTAL

hESC derived MSC like cell

Intervention Type BIOLOGICAL

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

Interventions

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hESC derived MSC like cell

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hong Chen, Doctor

Role: STUDY_DIRECTOR

Wuhan TongJi Hospital

Locations

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Tongji Hospital, Tongji Medical College of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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Wuhan Tongji Hospital

Identifier Type: -

Identifier Source: org_study_id

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