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

Primary Purpose

Osteochondritis, Osteochondritis Dissecans, Joint Diseases

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CS-ACI
Sponsored by
Yan Jin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteochondritis focused on measuring Cartilage repair, Cartilage defects, cell sheet, Autologous chondrocyte implantation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Xijing HospitalRecruiting
  • Tangdu HospitalRecruiting
  • Xi'An Honghui HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CS-ACI

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean change from baseline in the MRI

Secondary Outcome Measures

Change from Baseline in the Lysholm
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport

Full Information

First Posted
September 24, 2012
Last Updated
September 28, 2012
Sponsor
Yan Jin
Collaborators
Xijing Hospital, Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01694823
Brief Title
Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yan Jin
Collaborators
Xijing Hospital, Tang-Du Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteochondritis, Osteochondritis Dissecans, Joint Diseases
Keywords
Cartilage repair, Cartilage defects, cell sheet, Autologous chondrocyte implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CS-ACI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CS-ACI
Other Intervention Name(s)
Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）
Intervention Description
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）
Primary Outcome Measure Information:
Title
Mean change from baseline in the MRI
Time Frame
3month,6 month, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Change from Baseline in the Lysholm
Time Frame
3month,6 month, 12 months, 24 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Yan, Ph.D
Organizational Affiliation
Research and Development Center for Tissue Engineering,Fourth Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an Shi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhang Chunli, MD
Phone
86-029-84771339
Email
zhangcl816@sohu.com
First Name & Middle Initial & Last Name & Degree
zhang chunli, Ph.D
Facility Name
Tangdu Hospital
City
Xi'an Shi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ding yong, Ph.D
Phone
86-029-84717700
Email
dinyonza@fmmu.edu.cn
Facility Name
Xi'An Honghui Hospital
City
Xi'an Shi
ZIP/Postal Code
710054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zheng jiang
Phone
86-0 18802940279
Email
zhengjiang1010@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22369960
Citation
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.
Results Reference
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Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects

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