Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

This study has been completed.
Sponsor:
Information provided by:
Sewon Cellontech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01050816
First received: January 13, 2010
Last updated: May 6, 2010
Last verified: May 2010
  Purpose

An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.


Condition Intervention Phase
Articular Cartilage Defects of Ankle Joint
Procedure: Chondron(autologous chondrocyte) Implantation
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigator Clinical Trial to Observe Effects of CHONDRON (Autologous Chondrocytes) for 12 Months in Patients With Ankle Cartilage Defect

Resource links provided by NLM:


Further study details as provided by Sewon Cellontech Co., Ltd.:

Primary Outcome Measures:
  • Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ] [ Designated as safety issue: No ]

    AOFAS scores(best score-100,worst score- 0 )

    1. pain-none:40/Strong and Always present:O
    2. Function

      • activities-without support activities:10/need restrain, clutch , walker or wheelchair:0
      • Maximum gait distance- more than 6:5/ less than 1:0
      • gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0
      • Gait abnormality-none:8/marked:0
      • saggital mobidity- normal or minimal restrain:6/strong restraint:0
      • hindfoot mobidity -normal minimal restrain:6/strong restrain:0
      • ankle and hindfoot stability - stable:8/unstable:0
    3. alignment- good:10/bad:0


Secondary Outcome Measures:
  • Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ] [ Designated as safety issue: No ]

    A VAS is a horizontal line, 100mm in length, anchored by word descriptors about pain at each end.The VAS is measured degree of pain from 0mm to 100mm. Severe pain is represented by 100mm and no pain is represented by 0mm. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.

    The difference of secondary evaluation variables VAS at baseline and after the end of the trial were analyzed by using paired t-test. Improvements were compared and analysis by each time point.


  • Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ] [ Designated as safety issue: No ]
    The Modified Hannover Score System contains information about patient's status(pain-36, clinical finding- 4, patient's subjective assessment- 25, statics- 6, fuction- 26, radiology-7;best score-104, worst score-0).The scores of 27 patients in the FAS group were taken in the screening period (Visit S), 12 months after transplantation (Visit 7). The difference of the scores at screening and 12 months after transplantation was compared by using the paired t-test. Improvements were compared and analyzed at each time point.


Enrollment: 30
Study Start Date: January 2006
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chondron implantation
ankle cartilage defect patients who had CHONDRON transplantation
Procedure: Chondron(autologous chondrocyte) Implantation
  • Test drug: Chondron (more than 12 million chondrocytes in 0.4ml, i.e. 1 vial)
  • Directions and dosage:

Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected.

*30 subjects participated in this open clinical trial. Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received Gel type CHONDRON (fibrin mixed autologous chondrocytes) transplantation.

Other Name: Chondron

Detailed Description:

This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER score, self-assessment of improvement by the patient, MRI and arthroscopy.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. adult men and women over 15 and less than 65 years of age
  2. applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
  3. patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance.
  4. patients which surrounding cartilage are normal
  5. patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form

Exclusion Criteria:

  1. patients hypersensitive to bovine protein
  2. patients hypersensitive to gentamicin antibiotics
  3. patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
  4. patients with arthritis related to autoimmune disease
  5. pregnant, breast-feeding patients or those who have a possibility of pregnancy
  6. patients with accompanying diseases other than articular cartilage defects, including tumors
  7. patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
  8. patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded)
  9. patients who are administering antibiotics and antimicrobial agents due to infection
  10. patients who receive steroid hormone therapy
  11. Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050816

Locations
Korea, Republic of
Sewon Cellontech
Seoul, Sungdong-ku, Korea, Republic of, 133831
Sponsors and Collaborators
Sewon Cellontech Co., Ltd.
Investigators
Principal Investigator: Gyeung Tea Lee, MD Eulji General Hospital
  More Information

No publications provided

Responsible Party: Gyeong Tea , Lee, Eulji General Hospital
ClinicalTrials.gov Identifier: NCT01050816     History of Changes
Other Study ID Numbers: 02CON
Study First Received: January 13, 2010
Results First Received: January 21, 2010
Last Updated: May 6, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Sewon Cellontech Co., Ltd.:
articular cartilage defects
ACI
ankle joint
chondron

ClinicalTrials.gov processed this record on July 24, 2014