Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects (CS-ACI)
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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 |
- Mean change from baseline in the MRI [ Time Frame: 3month,6 month, 12 months, 24 months ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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 Musculoskeletal Diseases |
Bone Diseases Cartilage Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 21, 2013