Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

NCT01050816 | Completed Phase 3 Results DMC

• 1 other identifier: 02CON
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Articular Cartilage Defects of Ankle Joint

Keywords

articular cartilage defects; ACI; ankle joint; chondron

Outcome Measures

Primary Outcomes (1)

• Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months 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

  baseline(preoperative stage),12months post-surgery

Secondary Outcomes (2)

• Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery

  baseline(preoperative stage),12months post-surgery

• Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery

  baseline(preoperative stage),12months post-surgery

Study Arms (1)

Chondron implantation

EXPERIMENTAL

ankle cartilage defect patients who had CHONDRON transplantation

Procedure: Chondron(autologous chondrocyte) Implantation

Interventions

Chondron(autologous chondrocyte) Implantation PROCEDURE

* 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.

Also known as: Chondron

Chondron implantation

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adult men and women over 15 and less than 65 years of age
• applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
• 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.
• patients which surrounding cartilage are normal
• patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form

You may not qualify if:

• 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
• patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
• 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 who are administering antibiotics and antimicrobial agents due to infection
• patients who receive steroid hormone therapy
• Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager

Sponsors & Collaborators

• Sewon Cellontech Co., Ltd.: lead

Study Sites (1)

Sewon Cellontech

Seoul, Sungdong-ku, 133831, South Korea

Location

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Lee Gyeong Tae
• Organization: Eulji General Hospital

lkt2408@hanmail.net

+82-11-214-3323

Study Officials

• Gyeung Tea Lee, MD

  Eulji General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: January 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 11, 2010
• Results First Posted: May 7, 2010

Record last verified: 2010-05

Locations

KR (1)