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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Fourth Military Medical University
Sponsor:
Collaborators:
Xijing Hospital
Tang-Du Hospital
Information provided by (Responsible Party):
Yan Jin, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01694823
First received: September 24, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Osteochondritis
Osteochondritis Dissecans
Joint Diseases
Drug: CS-ACI
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Mean change from baseline in the MRI [ Time Frame: 3month,6 month, 12 months, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in the Lysholm [ Time Frame: 3month,6 month, 12 months, 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694823

Locations
China
Xijing Hospital Recruiting
Xi'an Shi, China, 710032
Contact: zhang Chunli, MD    86-029-84771339    zhangcl816@sohu.com   
Principal Investigator: zhang chunli, Ph.D         
Tangdu Hospital Recruiting
Xi'an Shi, China, 710038
Contact: ding yong, Ph.D    86-029-84717700    dinyonza@fmmu.edu.cn   
Xi'An Honghui Hospital Recruiting
Xi'an Shi, China, 710054
Contact: zheng jiang    86-0 18802940279    zhengjiang1010@126.com   
Sponsors and Collaborators
Yan Jin
Xijing Hospital
Tang-Du Hospital
Investigators
Study Director: Jin Yan, Ph.D Research and Development Center for Tissue Engineering,Fourth Military Medical University
  More Information

Publications:
Responsible Party: Yan Jin, Director of Research and Development Center for Tissue Engineering, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01694823     History of Changes
Other Study ID Numbers: CS-ACI2012001
Study First Received: September 24, 2012
Last Updated: September 28, 2012
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 28, 2014