Phase III Controlled Trial of gMSC1 in Patients with Symptomatic Articular Cartilage Defects or Osteochondritis Dissecans in the Knee

Phase 3

Completed

• Conditions: articular cartilage defects / osteochondritis dissecans in the knee

• Registration Number: JPRN-jRCT1080223548
• Lead Sponsor: TWOCELLS COMPANY, LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1) Articular cartilage defects / osteochondritis dissecans (OCD) in the knee
2) Index defects are International Cartilage Repair Society (ICRS) Articular cartilage injury classification Grade 3 or 4 cartilage defects or index defects are Nelson Grade 3 or 4 OCD lesions

Exclusion Criteria

1) Articular cartilage defects / osteochondritis dissecans (OCD) in the both knees
2) Osteoarthritis (narrowing of medial joint space>=1/3 compared to normal)
3) Ligament injury needs surgical treatment, or less than 4 weeks between surgical treatment for ligament injury and gMSC1 transplantation or MFx
4) Meniscus injury needs surgical treatment, or less than 6 weeks between surgical treatment for meniscus injury and gMSC1 transplantation or MFx. Regardless of the timing of surgical treatment for meniscus injury, meniscal resection of 50% and over
5) Less than 1 year between surgical treatment except debridement for the lesions and gMSC1 transplantation or MFx

Study & Design

• Study Type: Interventional
• Study Design: Not specified