Table II.
Overview of eight clinical trials for the treatment of knee disorders using decellularized tissue.
| Trial no. | Condition | Clinical trial name | Length | Status | Product name | Source tissue | Country | Hospital/Company | Clinical reports | Decellularization method/sterilization method |
|---|---|---|---|---|---|---|---|---|---|---|
| K1 | Cartilage injury | Chondrofix osteochondral allograft prospective study | 2011 to 2014 | Terminated (inadequate enrolment and decreased need for clinical data to support product) | Chondrofix | Human osteochondral plug | USA | Plancher Orthopaedics and Sports Medicine, Cartilage Repair Centre, Brigham and Women’s Hospital, Orthopaedic Research Foundation, etc/Zimmer Biomet | Farr21 | N/A; gamma irradiation, freezing22 |
| K2 | Cartilage injury | Second line treatment of knee osteochondral lesion with treated osteochondral graft | 2016 to 2021 | Terminated (low accrual rate) | OD-PHOENIX | Human osteochondral plug | France | TBF Genie Tissulaire | N/A | N/A; gamma irradiation (25 to 32 kGy), freezing23 |
| K3 | Cartilage injury | Clinical study of decalcification bone scaffold for cartilage lesions of the knee | 2018 to 2023 | Recruiting | N/A | Decalcification bone | China | Peking University Third Hospital | N/A | N/A |
| K4 | Cartilage injury | Clinical trial to evaluate the efficacy and safety of MegaCarti in knee cartilage defects | 2020 to 2027 | Active, not recruiting | MegaCarti | Human cartilage | South Korea | Yonsei University Health System, Gangnam Severance Hospital/L&C Bio | N/A | N/A; gamma irradiation24 |
| K5 | ACL injury | Safety and efficacy study of the Z-Lig medical device compared to allograft | 2010 to ? | Unknown status | Z-Lig | Porcine bone-patellar tendon | Belgium, Italy, Netherlands, South Africa, Spain | Ghent University Hospital, Aarhus University Hospital, Istituti Ortopedici Rizzoli, etc/Aperion Biologics | Zaffagnini25 | Enzymes and α-galactosidase/electron irradiation26 |
| K6 | ACL injury | OrthoPure XT pilot clinical study | 2018 to 2020 | Withdrawn (unspecified business decision/strategic reason) | OrthoPure XT | Porcine tendon | USA | St. Joseph’s Outpatient Surgery Centre, OrthoIndy Hospital South, Jewish Hospital/TRX Orthopedics | Hunt27 | 0.1% sodium dodecyl sulfate and protease inhibitor28/antibiotics, peracetic acid29 |
| K7 | ACL injury | Clinical evaluation of dCELL ACL scaffold for reconstruction of the anterior cruciate ligament | 2015 to 2021 | Active, not recruiting | dCELL ACL scaffold | Porcine tendon | Poland, Spain, UK | Robert Jones and Agnes Hunt Hospital NHS Foundation Trust, Hospital Universitari de Bellvitage, Klinika Chirurgii Endoskopowej Sp. z o.o. etc/Tissue Regenix | Hunt27 | 0.1% sodium dodecyl sulfate and protease inhibitor28/antibiotics, peracetic acid29 |
| K8 | Meniscus injury | Clinical evaluation of dCELL meniscus for partial arthroplasty of the meniscus | 2014 to 2018 | Suspended | dCELL meniscus | Porcine meniscus | Poland, UK | "Ortotrauma" Spółka Z Ograniczoną, The Hillingdon Hospitals NHS Foundation Trust, the Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust/Tissue Regenix | N/A | 0.1% sodium dodecyl sulfate and protease inhibitor;28,30 N/A |
ACL, anterior cruciate ligament; N/A, not available.