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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01694823

Acronym

CS-ACI

Enrollment

Registered

2012-09-27

Start date

2012-04-30

Completion date

2015-06-30

Last updated

2012-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Diseases, Osteochondritis, Osteochondritis Dissecans

Keywords

Cartilage repair, Cartilage defects, cell sheet, Autologous chondrocyte implantation

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.

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.

Interventions

DRUGCS-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）

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change from Baseline in the Lysholm	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	3month,6 month, 12 months, 24 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026