None listed
Conditions
Brief summary
Articular cartilage is aneural, avascular and has limited capacity for self-repair. Articular cartilage defects pre-dispose patients to developing osteoarthritis, and if left un-treated, damage can become so severe that joint replacement is indicated. Autologous Matrix-Induced Chondrogenesis (AMIC) is an enhanced version of the original microfracture technique, in which a type I/III collagen matrix (Chondro-Gide, Registered Trademark) is placed over the cartilage defect to stabilise the fragile bone marrow cell infiltrate and provide infrastructure for tissue repair and regeneration. Currently, the majority of commercially available collagen membranes are manufactured in Europe or the USA from locally-produced source material. Australian-sourced biological materials are valued due to the historically low rate of zoonotic infectious diseases and absence of transmissible spongiform encephalitis. CelGro (Trademark) is manufactured in Australia, using collagen originating from Australian Government veterinarian-certified animals bred and raised in Western Australia, eliminating disease transmission concerns associated with foreign products. This study will use CelGro (Trademark) as the collagen matrix in AMIC treatment for osteochondral defect in the hip.
Interventions
Participants will undergo a single autologous Matrix-Induced Chondrogenesis (AMIC) procedure conducted by an orthopaedic surgeon. AMIC is an enhanced version of the original microfracture technique in which a type I/III collagen matrix (Chondro-Gide, Trademark) is placed over the cartilage defect to stabilise the fragile bone marrow cell infiltrate and provide infrastructure for tissue repair and regeneration. AMIC is an effective treatment for chondral lesions of the knee, ankle and hip, and ca
Participants will undergo a single autologous Matrix-Induced Chondrogenesis (AMIC) procedure conducted by an orthopaedic surgeon. AMIC is an enhanced version of the original microfracture technique in which a type I/III collagen matrix (Chondro-Gide, Trademark) is placed over the cartilage defect to stabilise the fragile bone marrow cell infiltrate and provide infrastructure for tissue repair and regeneration. AMIC is an effective treatment for chondral lesions of the knee, ankle and hip, and can be performed arthroscopically, reducing total treatment time and minimising morbidity. The procedure takes between 1-2 hours, inclusive of recovery time. A single CelGro (Trademark) membrane will be used in the AMIC procedure. CelGro (Trademark) is a type I/III collagen matrix obtained by a standardised, controlled manufacturing process. The collagen is of porcine origin and is carefully purified to remove foreign DNA and other substances that could provoke immunogenic reactions. CelGro (Trademark) has a bilayer structure with a porous side that allows for the ingrowth of cells. The scaffold consists of natural collagen without further cross-linking or chemical additives. CelGro (Trademark) is delivered sterile in a sealed pouch and presents as a white to off-white sheet with both a smooth and slightly rougher surface.
Sponsors
Orthocell Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
- Male or female between 18-55 years of age - Acetabular osteochondral defect (Outerbridge grade III or IV) measuring 2-8cm2 - Radiologically confirmed Tonnis grade < 2 - Able to comply with the requirements of the protocol, including post-treatment rehabilitation - Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP
Exclusion criteria
- Concomitant presence of femoral head chondral lesion (kissing lesion) - Rheumatoid arthritis - Dysplasia - Femoral neck axial deviation - Coxa profunda - Protrusio acetabuli - Active infection or systemic pathology including inflammatory joint disease, HIV, uncontrolled or poorly controlled diabetes, hepatitis or neoplastic disorders - Known hypersensitivity to the study treatment or its excipients or known relevant medication allergy - Female participant who is pregnant or lactating - Known substance abuse - Participation in another study with an investigational product within 3 months of visit 1 - Concurrent medical condition which precludes the administration of study treatment - Other clinically significant disease (including psychological disorders) or medical condition that would, in the opinion of the Investigator, compromise the safety of the participant or the outcome of the study
Outcome results
None listed