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Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050816
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : May 7, 2010
Last Update Posted : May 11, 2010
Information provided by:
Sewon Cellontech Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Articular Cartilage Defects of Ankle Joint Procedure: Chondron(autologous chondrocyte) Implantation Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

    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 :
  1. Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ]

    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.

  2. Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050816

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

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Responsible Party: Gyeong Tea , Lee, Eulji General Hospital Identifier: NCT01050816     History of Changes
Other Study ID Numbers: 02CON
First Posted: January 15, 2010    Key Record Dates
Results First Posted: May 7, 2010
Last Update Posted: May 11, 2010
Last Verified: May 2010
Keywords provided by Sewon Cellontech Co., Ltd.:
articular cartilage defects
ankle joint
Additional relevant MeSH terms:
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Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases