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

Joint Diseases Clinical Trial

— CS-ACI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01694823
• Other study ID #: CS-ACI2012001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 24, 2012
• Last updated: September 28, 2012
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2012
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cartilage Diseases
• Joint Diseases
• Osteochondritis
• Osteochondritis Dissecans

Intervention

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)

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an Shi
China	Xi'An Honghui Hospital	Xi'an Shi
China	Xijing Hospital	Xi'an Shi

Sponsors (3)

Lead Sponsor	Collaborator
Yan Jin	Tang-Du Hospital, Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in the MRI		3month,6 month, 12 months, 24 months	No
Secondary	Change from Baseline in the Lysholm		3month,6 month, 12 months, 24 months	No
Secondary	Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport		3month,6 month, 12 months, 24 months	No