NCT01694823

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2012

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 1, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

September 24, 2012

Last Update Submit

September 28, 2012

Conditions

OsteochondritisOsteochondritis DissecansJoint Diseases

Keywords

Cartilage repairCartilage defectscell sheetAutologous chondrocyte implantation

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in the MRI

    3month,6 month, 12 months, 24 months

Secondary Outcomes (2)

  • 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

Study Arms (1)

CS-ACI

EXPERIMENTAL

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

Interventions

CS-ACIDRUG

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）

Also known as: Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）
CS-ACI

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Xijing Hospital

Xi'an, 710032, China

RECRUITING

Tangdu Hospital

Xi'an, 710038, China

RECRUITING

Xi'An Honghui Hospital

Xi'an, 710054, China

RECRUITING

Related 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.

    PMID: 22369960BACKGROUND

MeSH Terms

Conditions

OsteochondritisOsteochondritis DissecansJoint Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesCartilage DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jin Yan, Ph.D

    Research and Development Center for Tissue Engineering,Fourth Military Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Research and Development Center for Tissue Engineering

Study Record Dates

First Submitted

September 24, 2012

First Posted

September 27, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Study Completion

June 1, 2015

Last Updated

October 1, 2012

Record last verified: 2012-09

Locations

CN(3)