Working... Menu
Trial record 19 of 23 for:    Osteochondritis Dissecans

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01694823
Recruitment Status : Unknown
Verified September 2012 by Yan Jin, Fourth Military Medical University.
Recruitment status was:  Recruiting
First Posted : September 27, 2012
Last Update Posted : October 1, 2012
Xijing Hospital
Tang-Du Hospital
Information provided by (Responsible Party):
Yan Jin, Fourth Military Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteochondritis Osteochondritis Dissecans Joint Diseases Drug: CS-ACI Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : June 2015

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 Name: Cells Sheet-Autologous Chondrocyte Implantation( CS-ACI)

Primary Outcome Measures :
  1. Mean change from baseline in the MRI [ Time Frame: 3month,6 month, 12 months, 24 months ]

Secondary Outcome Measures :
  1. Change from Baseline in the Lysholm [ Time Frame: 3month,6 month, 12 months, 24 months ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01694823

Layout table for location information
Xijing Hospital Recruiting
Xi'an Shi, China, 710032
Contact: zhang Chunli, MD    86-029-84771339   
Principal Investigator: zhang chunli, Ph.D         
Tangdu Hospital Recruiting
Xi'an Shi, China, 710038
Contact: ding yong, Ph.D    86-029-84717700   
Xi'An Honghui Hospital Recruiting
Xi'an Shi, China, 710054
Contact: zheng jiang    86-0 18802940279   
Sponsors and Collaborators
Yan Jin
Xijing Hospital
Tang-Du Hospital
Layout table for investigator information
Study Director: Jin Yan, Ph.D Research and Development Center for Tissue Engineering,Fourth Military Medical University

Layout table for additonal information
Responsible Party: Yan Jin, Director of Research and Development Center for Tissue Engineering, Fourth Military Medical University Identifier: NCT01694823     History of Changes
Other Study ID Numbers: CS-ACI2012001
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: October 1, 2012
Last Verified: September 2012

Keywords provided by Yan Jin, Fourth Military Medical University:
Cartilage repair
Cartilage defects
cell sheet
Autologous chondrocyte implantation

Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Cartilage Diseases
Osteochondritis Dissecans
Musculoskeletal Diseases
Connective Tissue Diseases
Bone Diseases