Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects (CS-ACI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Fourth Military Medical University.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Yan Jin, Fourth Military Medical University
First received: September 24, 2012
Last updated: September 28, 2012
Last verified: September 2012
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
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.
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）
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.
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Patients younger than 18 years and older than 50 years.
- Arthrofibrosis or Ankylosis
- Infectious diseases
- the other cases of patients which Doctors determine not participate in the trial
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01694823
|Xi'an Shi, China, 710038 |
|Contact: ding yong, Ph.D 86-029-84717700 firstname.lastname@example.org |
|Xi'An Honghui Hospital
|Xi'an Shi, China, 710054 |
|Contact: zheng jiang 86-0 18802940279 email@example.com |
|Xi'an Shi, China, 710032 |
|Contact: zhang Chunli, MD 86-029-84771339 firstname.lastname@example.org |
|Principal Investigator: zhang chunli, Ph.D |
||Jin Yan, Ph.D
||Research and Development Center for Tissue Engineering,Fourth Military Medical University
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.
||Yan Jin, Director of Research and Development Center for Tissue Engineering, Fourth Military Medical University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2012
||September 28, 2012
||China: Ethics Committee
Keywords provided by Fourth Military Medical University:
Autologous chondrocyte implantation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2015
Connective Tissue Diseases