Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle

NCT02537067 | Terminated Phase 3 DMC

• 1 other identifier: 04CON
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus Chondrocyte) in patients with cartilage defects in their ankle for 18 months

Conditions

Defect of Articular Cartilage; Degenerative Joint Disease of Ankle and/or Foot; Ankle (Ligaments); Instability, Familial

Keywords

a partial cartilage defect of ankle; Chondron; Autologus Chondrocyte

Outcome Measures

Primary Outcomes (1)

• Grade change of ICRS(International Cartilage Repair Society) by arthroscopy

  The change of ICRS grade of the affected ankle shall be assessed at 12 months after the surgery. The results on the surgery date shall be considered the baseline data and shall be compared with those at 12 months after the surgery based on arthroscopy. For the final efficacy evaluation, the percentage of the patients (success rate) who showed Grade III or IV ICRS before the surgery and improved to Grade 0 or I after the surgery will be calculated.

  12 months after the surgery

Secondary Outcomes (5)

• Score change of AOFAS(American orthopedic foot & ankle society) Score

  baseline and six, 12 and 18 months after the surgery

• Hannover Score

  baseline and six, 12 and 18 months after the surgery

• Score change of Evaluation by physician in charge

  six, 12 and 18 months after the surgery

• Score change of 100mmVAS(visual analogue scale)

  baseline and six, 12 and 18 months after the surgery

• Comparing MRI results

  baseline and 18 months after the surgery

Study Arms (1)

Autologous cultured Chondrocyte

EXPERIMENTAL

Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant.

Drug: CHONDRON

Interventions

CHONDRON DRUG

1. Harvesting of ankle or knee cartilage 2. The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.

Also known as: Autologous cultured Chondrocyte

Autologous cultured Chondrocyte

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 15 to 65 years
• Patients with MRI-confirmed partial cartilage defects of the ankle (≤15 cm² single lesion, ≤20 cm² multiple lesions)
• Patients who have undergone correction for malalignment, ligament instability, or bone defects (if applicable)
• Patients with normal surrounding cartilage
• Patients with ICRS Grade III or IV cartilage defects
• Subjects who provide written informed consent

You may not qualify if:

• Hypersensitivity to bovine protein or gentamicin
• Inflammatory or autoimmune arthritis (e.g., rheumatoid arthritis, gout)
• Pregnant, breastfeeding, or planning pregnancy
• Tumors or serious comorbid conditions
• History of radiotherapy or chemotherapy within 2 years
• Uncontrolled diabetes or diabetes with complications
• Active infection requiring antibiotics
• Current corticosteroid therapy
• Patients with mental illness or other conditions deemed unsuitable for this study by the clinical trial manager

Sponsors & Collaborators

• Cellontech Co., Ltd.: lead

Study Sites (2)

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

Location

Eulji General Hospital

Seoul, Seoul, South Korea

Location

Study Officials

• Jin Su Kim, MD

  Eulji General Hospital

  PRINCIPAL INVESTIGATOR

• Ki Hyuck Sung, MD

  Myongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: September 1, 2015
• Study Start: January 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 8, 2026

Record last verified: 2016-11

Locations

KR (2)