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The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte)

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ClinicalTrials.gov Identifier: NCT02539056
Recruitment Status : Unknown
Verified August 2015 by Sewon Cellontech Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Sewon Cellontech Co., Ltd.

Brief Summary:
A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects in their knees.

Condition or disease Intervention/treatment Phase
Osteoarthritis Traumatic Arthritis Device: Chondron Implantation Phase 4

Detailed Description:
This is an open trial, involving a total of 24 subjects. Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. During the trial period, subjects must follow the instructions given by principal investigator. Subjects will make 8* hospital visits on a regular basis inclusive of hospitalization. During these visits subjects will be examined. For the evaluation of safety and efficacy of CHONDRON, examination with doctors, blood samples, x-ray, MRI tests, observation with the naked eyes and arthroscopy will be performed. *If tissue samples can be collected at screening visit, there will be only 7 visits.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: This Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte) in Patients With Cartilage Defects in Their Knees.
Study Start Date : July 2012
Actual Primary Completion Date : February 2015
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chondron Implantation
Chondron Implantation for the suject with cartilage defect
Device: Chondron Implantation
In one vial (0.4 ml), Main ingredient: 1.2 million or more autologous chondrocytes Culture solution: Adequate amount of Dulbecco's modified Eagle medium (DMEM) The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.




Primary Outcome Measures :
  1. change in pain of 100mm Visual Analog Scale [ Time Frame: 48 weeks after the surgery ]
    The primary endpoint for the analysis is the change in the 100mmVAS at 48 weeks after the surgery from that of baseline.


Secondary Outcome Measures :
  1. change of IKDC (International Knee Documentation Committee) [ Time Frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery ]
    The IKDC values of the affected knee at basleine and 48 weeks after the surgery will be primarily compared based on the evaluations by the subjects and the investigators (and 12, 24 and 96 weeks after the surgery).

  2. Chnage of KSS(Knee Society Score) [ Time Frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery ]
    The primary endpoint for the analysis is the change in the KSS at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).

  3. Chnage of ICRS(International Cartilage Repair Society) score [ Time Frame: baseline and 48 weeks after the surgery ]
    The ICRS grades of the affected knee at baseline and 48 weeks after the surgery will be primarily compared

  4. Chnage of KOOS(Knee injury and osteoarthritis outcome) score [ Time Frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery ]
    The primary endpoint for the analysis is the change in the KOOS at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).

  5. Change of MRI and mMOCART result [ Time Frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery ]
    The morphological improvement of MRI image for the affected knee at baseline will be compared with those at 48 weeks after the surgery (and 12, 24, and 96weeks after the surgery). The primary endpoint for the analysis is the change in the mMOCART at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).

  6. change in pain of 100mm Visual Analog Scale [ Time Frame: baseline, 12, 24 and 96 weeks after the surgery ]
    The change in the 100mmVAS will be assessed at baseline and 12, 24 and 96 weeks after the surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with cartilage defects in their knee (Including Knee OA and Knee TA) * For a single lesion, less than 15 cm2 cartilage defects; and for multiple lesions, less than 20 cm2
  2. Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment
  3. Patients which surrounding cartilage are normal
  4. Patients who were 15 years old or older
  5. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed 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 (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
  7. Patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
  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 with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
  10. Patients under adrenocorticoid therapy (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
  11. Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
  12. Patients with cartilage defects in both knees (If the necessity of other surgery on the opposite side of knee joint using Chondron is confirmed with doctor's clinical decision).
  13. Patients with liver, heart, or kidney disease (Those who show normal or insignificant test results may be enrolled in this study and receive the Chondron based on the investigator's judgment. Hypertension patients are allowed.)
  14. Patients who had been infected with a virus (Those who show normal or insignificant test results may be enrolled in this study and receive the Chondron based on the investigator's judgment.)
  15. Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)

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 ClinicalTrials.gov identifier (NCT number): NCT02539056


Locations
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Korea, Republic of
Inha Univerisity Hospital
Incheon, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Sewon Cellontech Co., Ltd.
Investigators
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Principal Investigator: Myung Ku Kim, MD Inha University Hospital
Principal Investigator: Jae Doo Yoo, MD Ewha Womans University Mokdong Hospital

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Responsible Party: Sewon Cellontech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02539056     History of Changes
Other Study ID Numbers: 08CON
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015

Keywords provided by Sewon Cellontech Co., Ltd.:
cartilage defects
Chondron
Autologous cultured Chondrocyte

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases