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Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects

NCT ID: NCT01694823

Last Updated: 2012-10-01

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/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-06-30

Brief Summary

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In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated.

Detailed Description

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All procedures are carried out after obtaining informed written consent from patients. Cartilage tissue is acquired from the Non-weight-bearing area of patients. chondrocyte are isolated and grown in culture for 6-8 weeks. After this time interval, the cells are reprocessed and the cell sheet is obtained. Implantation of the chondrocyte sheet into the Cartilage defect of the keen.The patients will be assessed clinically with scoring systems preoperatively as well as 24 months postoperatively to assess relief of symptoms and joint function. Radiological assessment (MRIs)of the affected joints will be performed at the same time points aforementioned to assess integrity of the formed cartilage. Second look arthroscopy and biopsy will also be performed to histologically assess the repair tissue and grade it via arthroscopic grading system according to the International Cartilage Repair Society guidelines.

Conditions

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Osteochondritis Osteochondritis Dissecans Joint Diseases

Keywords

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Cartilage repair Cartilage defects cell sheet Autologous chondrocyte implantation

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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CS-ACI

Group/Cohort Label： pretherapy post-treatment

Group/Cohort Description ：The CS-ACI is used to prepare cell sheet and implant to the Cartilage defects.The arm of safety and efficacy are compared preoperative observation with postoperative observation.

Group Type EXPERIMENTAL

CS-ACI

Intervention Type DRUG

Procedure: Self-control. Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) includes an arthroscopy for harvesting of cartilage 6-8 weeks prior to the open cartilage surgery. Other Names:

Cells Sheet-Autologous Chondrocyte Implantation （CS-ACI）

Interventions

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CS-ACI

Procedure: Self-control. Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) includes an arthroscopy for harvesting of cartilage 6-8 weeks prior to the open cartilage surgery. Other Names:

Cells Sheet-Autologous Chondrocyte Implantation （CS-ACI）

Intervention Type DRUG

Other Intervention Names

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Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）

Eligibility Criteria

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Inclusion Criteria

* Male or female patients, age: between 18 and 50 years
* Defect: isolated ICRS grade III or IV single defect chondral lesions on Articular Cartilage
* Defect size: 2.5 to \< 5 cm2 after debridement to healthy cartilage up to 6 mm in depth.
* Nearly intact chondral structure surrounding the defect as well as an intact corresponding joint area
* Informed consent signed and dated by patient and Patient understands the strict rehabilitation protocol and follow-up programme and is willing to follow it
* No ligament damage or ligament damage after reconstruction

Exclusion Criteria

* Patients younger than 18 years and older than 50 years.
* Arthrofibrosis or Ankylosis
* Arthritis
* Obesity
* Infectious diseases
* the other cases of patients which Doctors determine not participate in the trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role collaborator

Yan Jin

OTHER

Sponsor Role lead

Responsible Party

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Yan Jin

Director of Research and Development Center for Tissue Engineering

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jin Yan, Ph.D

Role: STUDY_DIRECTOR

Research and Development Center for Tissue Engineering,Fourth Military Medical University

Locations

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Xijing Hospital

Xi'an, , China

Site Status RECRUITING

Tangdu Hospital

Xi'an, , China

Site Status RECRUITING

Xi'An Honghui Hospital

Xi'an, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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zhang Chunli, MD

Role: primary

ding yong, Ph.D

Role: primary

zheng jiang

Role: primary

References

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Ebihara G, Sato M, Yamato M, Mitani G, Kutsuna T, Nagai T, Ito S, Ukai T, Kobayashi M, Kokubo M, Okano T, Mochida J. Cartilage repair in transplanted scaffold-free chondrocyte sheets using a minipig model. Biomaterials. 2012 May;33(15):3846-51. doi: 10.1016/j.biomaterials.2012.01.056. Epub 2012 Feb 25.

Reference Type BACKGROUND
PMID: 22369960 (View on PubMed)

Other Identifiers

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CS-ACI2012001

Identifier Type: -

Identifier Source: org_study_id