osteochondral defects of the knee (early osteoarthritis) MedDRA version: 14.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: Autologous chondrocytes
Product Code: N/A
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: autologous chondrocytes
Concentration unit: Other
Concentration type: range
C
Sponsors
RJAH Orthopaedic Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A symptomatic chondral defect of the knee that extends to (Outerbridge grade 4) or into the subchondral bone. 2. The defect is considered suitable for treating with autologous cell therapy. 3. Previous surgical treatment of the defect has failed to relieve symptoms. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Positive for HIV, hepatitis B or C, syphilis, or human T cell lymphotrophic virus (HTLV) I or II. 2. Likely to show contraindications to autologous cell therapy: patients with inflammatory condition, history of mesenchymal tumours, therapy with steroids or methotrexate, bleeding tendency or known anaphylaxis to any product used in cell preparation. 3. Low probability of compliance with physiotherapy or follow-up, including a major life-threatening condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research question is to find out if treatment with either a patient's own cartilage cells (chondrocytes), or bone marrow-derived stromal cells (containing stem cells), or a combination of the two cell types, give a different clinical outcome, in terms of knee function, for patients with early osteoarthritis of the knee.;Secondary Objective: Do different cell types (cartilage cells, bone marrow-derived stem cells, or a combination) give a different quality of structural cartilage repair as judged by histology, MRI images and arthroscopic score? Do different cell types delay or prevent joint replacement to a different degree? How do cell therapies help cartilage and bone regeneration? Can we optimise cell therapy according to patient selection, cell culture characteristics, manner of implantation and method of rehabilitation? How do the treatment costs compare between the three treatments?;Primary end point(s): The Lysholm Score: A measure of clinical and functional outcome that has been optimised for patients who have undergone cell therapy for joint damage of the knee.;Timepoint(s) of evaluation of this end point: 15 months after cell implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of adverse events 2. Quality of repair tissue using MRI and histology of cartilage biopsy (currently unfunded,the ability to investigate this outcome is contingent on obtaining sufficient funding) 3. Health related quality of life and other patient-reported outcome measures 4. Number of years free from further surgery 5. Observed patterns of rehabilitation and compliance to physiotherapy schedules 6. Unit costs per treatment;Timepoint(s) of evaluation of this end point: 1. Adverse events and Serious adverse events will be recorded until 15 months post cell implantation. This constitutes the defined 'end of trial'. However, a non-interventional follow-up phase will continue until Year 20 whereby critical SAE's, as defined in the study protocol, will be captured using databases such as national cancer and joint replacement registries. 2 & 3. 15 months post cell implantation. 4. Up to 20 years post cell implantation 5 & 6. 15 months post cell implantation. | — |
Countries
United Kingdom
Outcome results
None listed