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

September 28, 2012 updated by: Yan Jin

A Prospective Open-label Multi-center Study to Demonstrate the Safety and Efficacy of Cells Sheet-Autologous Chondrocyte Implantation（CS-ACI）for the Treatment of Articular Cartilage Defects

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • 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
      • Xi'an Shi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:
        • Principal Investigator:
          • zhang chunli, Ph.D
      • Xi'an Shi, China, 710038
        • Recruiting
        • Tangdu Hospital
        • Contact:
      • Xi'an Shi, China, 710054
        • Recruiting
        • Xi'an Honghui Hospital
        • Contact:

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

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: 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）

Other Names:
  • Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in the MRI
Time Frame: 3month,6 month, 12 months, 24 months
3month,6 month, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the Lysholm
Time Frame: 3month,6 month, 12 months, 24 months
3month,6 month, 12 months, 24 months
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport
Time Frame: 3month,6 month, 12 months, 24 months
3month,6 month, 12 months, 24 months

Collaborators and Investigators

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

Sponsor

Yan Jin

Collaborators

Xijing Hospital
Tang-Du Hospital

Investigators

  • Study Director: Jin Yan, Ph.D, Research and Development Center for Tissue Engineering,Fourth Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2013

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (ESTIMATE)

September 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-ACI2012001

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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