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

Primary Purpose

Osteoarthritis, Traumatic Arthritis

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Chondron Implantation

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring cartilage defects, Chondron, Autologous cultured Chondrocyte

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
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
Patients which surrounding cartilage are normal
Patients who were 15 years old or older
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:

Patients hypersensitive to bovine protein
Patients hypersensitive to gentamicin antibiotics
Patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
Patients with arthritis related to autoimmune disease
Pregnant, breast-feeding patients or those who have a possibility of pregnancy
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).
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).
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)
Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
Patients under adrenocorticoid therapy (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
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).
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.)
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.)
Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)

Sites / Locations

Inha Univerisity Hospital
Ewha Womans University Mokdong Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chondron Implantation

Arm Description

Chondron Implantation for the suject with cartilage defect

Outcomes

Primary Outcome Measures

change in pain of 100mm Visual Analog Scale

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

change of IKDC (International Knee Documentation Committee)

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).

Chnage of KSS(Knee Society Score)

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).

Chnage of ICRS(International Cartilage Repair Society) score

The ICRS grades of the affected knee at baseline and 48 weeks after the surgery will be primarily compared

Chnage of KOOS(Knee injury and osteoarthritis outcome) score

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).

Change of MRI and mMOCART result

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).

change in pain of 100mm Visual Analog Scale

The change in the 100mmVAS will be assessed at baseline and 12, 24 and 96 weeks after the surgery.

Full Information

NCT ID

NCT02539056

First Posted

August 28, 2015

Last Updated

September 1, 2015

Sponsor

Sewon Cellontech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02539056

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sewon Cellontech Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Traumatic Arthritis

Keywords

cartilage defects, Chondron, Autologous cultured Chondrocyte

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chondron Implantation

Arm Type

Experimental

Arm Description

Chondron Implantation for the suject with cartilage defect

Intervention Type

Device

Intervention Name(s)

Chondron Implantation

Intervention Description

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 Measure Information:

Title

change in pain of 100mm Visual Analog Scale

Description

The primary endpoint for the analysis is the change in the 100mmVAS at 48 weeks after the surgery from that of baseline.

Time Frame

48 weeks after the surgery

Secondary Outcome Measure Information:

Title

change of IKDC (International Knee Documentation Committee)

Description

Time Frame

baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery

Title

Chnage of KSS(Knee Society Score)

Description

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).

Time Frame

baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery

Title

Chnage of ICRS(International Cartilage Repair Society) score

Description

The ICRS grades of the affected knee at baseline and 48 weeks after the surgery will be primarily compared

Time Frame

baseline and 48 weeks after the surgery

Title

Chnage of KOOS(Knee injury and osteoarthritis outcome) score

Description

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).

Time Frame

baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery

Title

Change of MRI and mMOCART result

Description

Time Frame

baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery

Title

change in pain of 100mm Visual Analog Scale

Description

The change in the 100mmVAS will be assessed at baseline and 12, 24 and 96 weeks after the surgery.

Time Frame

baseline, 12, 24 and 96 weeks after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Patients which surrounding cartilage are normal Patients who were 15 years old or older 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: Patients hypersensitive to bovine protein Patients hypersensitive to gentamicin antibiotics Patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis Patients with arthritis related to autoimmune disease Pregnant, breast-feeding patients or those who have a possibility of pregnancy 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). 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). 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) Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents Patients under adrenocorticoid therapy (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision). Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager 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). 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.) 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.) Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myung Ku Kim, MD

Organizational Affiliation

Inha University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jae Doo Yoo, MD

Organizational Affiliation

Ewha Womans University Mokdong Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inha Univerisity Hospital

City

Incheon

Country

Korea, Republic of

Facility Name

Ewha Womans University Mokdong Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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