focal articular cartilage lesion in the knee
Conditions
Interventions
To transplant autologous cultured chondrocyte processed product (IK-01) for focal articular cartilage defects
Sponsors
Ryosuke Kuroda, M.D., Ph.D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patient more than 20 years and less than 50 years on obligation of the informed consent 2. patient obligated informed consent in written 3. patient with IKDC score < 60 in screening period 4. patient with focal articular cartilage lesions in the knee (including osteochondritis dissecans ) 5.patient with III or IV in either ICRS or Outerbridge category. 6. patient with III or IV in nelson category by MRI image in the case of osteochondritis dissecans 7. patient with solid articular cartilage confirmed after debrided by knee arthroscopy in the case of the surface of articular cartilage lesion < 9 cm2 8. patient treated with existing standard therapy (ex; microfrature, mosaicplasty and so on) in the case of the surface of articular cartilage lesion < 4 cm2
Exclusion criteria
Exclusion criteria: 1. patient with knee osteoarthritis (articluar cartilage changed denatuation) 2. patient with more than one site of arthropathia in lower extremity 3. patient with more than two sites of articular cartilage lesions, or focal cartilage lesions on both sides of kneejoints that need for treatment 4. patient with gout or pseudogout 5. patient with articular cartilage lesions in both articular surface and other side surface 6. patient with paralysis associated with neurological disease 7. patient need for bone transplantation from other site, for example, ilium (excluding removal of free bone fragment and irrigation of lesion site) 8. patient with a history of surgery or its need, for example of ablation or suturation of knee meniscus in injured side, but except in the presence of passed consistent term (8 wks over) after surgery of ablation or suturation of maximum partial knee meniscus of 1/3 9. patient with a history of surgery or its need, for example of ligament reconstruction of knee in diseased side, but except in the presence of passed consistent term (8 wks over) after surgery of ablation or suturation of knee meniscus 10. patient with a history of allergic reaction to collagen-containing products 11. patient with a history of serious hypersensitivity or anaphylactic shock to fibrin glue (Bolheal)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IKDC score: assessment of delta IKDC score at 52wks after operation compared with score at pre-operation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.IKDC score: assessment of delta IKDC score at 4wks, 12wks, 24wks and 36wks after operation and discontinuation compared with score at pre-operation 2.Lysholm score, VAS: assessment of deltaIKDC score at 4wks, 12wks, 24wks, 36wks and 52wks after operation and/or discontinuation compared with score at pre-operation 3.Histological assessment of the site of transplantation of IK-01 (knee arthroscopy, knee X-ray, knee MRI, hardness of the articular cartilage tissue) :assessment of the status of site of transplantation at 2wks, 12wks, 24wks and 52wks after operation and/or discontinuation X-ray image and hardness of the articular cartilage tissue measured by biosensor at operation of IK-01 transplantation in the knee, and MRI image at 2wks after operation are used as baseline , assessment of surface structure, congruity around tissue, mechanical strength of cartilage tissue and quality of reproduced cartilage tissue on the site of transplantation of IK-01 on each point are evaluated global (as X-ray image and MRI image as assessment at 12wks, 24wks, 52wks after operation and/or discontinuation, as hardness of the articular cartilage tissue as assessment at 52wks and/or discontinuation) | — |
Countries
Japan
Contacts
Public ContactJunko Yamasaki
Kobe University Hospital Center for Clinical Reserch
Outcome results
None listed