Osteochondral Defects Clinical Trial
— OMCMOfficial title:
A Prospective, Open Label, Multi-centre, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects
Verified date | September 2011 |
Source | TiGenix n.v. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Observational |
The objective of this post-marketing study is to confirm the clinical efficacy and safety
outcome of treatment with ChondroMimetic in a patient population within the proposed
indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up
period.
The primary objective is to collect post-marketing safety data in a real life setting by
means of (S)ADR reporting.
The secondary objectives are:
- Clinical outcome as assessed by patient reported EuroQoL-5D
- Structural repair as assessed by MRI
- The number of treatment failures and the time to treatment failure
- The ease of use of ChondroMimetic as reported by the surgeon
Status | Terminated |
Enrollment | 8 |
Est. completion date | April 2016 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Signed patient informed consent 2. Shallow osteochondral defect = 12 mm diameter and = 8 mm depth in weight bearing area 3. Agree to actively participate in a rehabilitation protocol Exclusion Criteria: 1. Severe vascular or neurological disease 2. Uncontrolled diabetes 3. Severe degenerative joint disease 4. Pregnancy 5. Presence of infection at the site or in the joint space (e.g. osteomyelitis) 6. Diagnosis rheumatoidism 7. Advanced osteoarthritis as judged by the surgeon 8. Drug and/or alcohol abuse 9. Hypercalcemia 10. Known allergy to any of the components of the device (e.g. bovine collagen) 11. Bleeding disorders of any etiology 12. Steroidal or immunosuppressive maintenance therapy |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven | Leuven | |
Germany | Universitätsklinikum Freiburg | Freiburg | |
Hungary | Uzsoki Hospital | Budapest | |
United Kingdom | Addenbrookes Hospital | Cambridge |
Lead Sponsor | Collaborator |
---|---|
TiGenix n.v. |
Belgium, Germany, Hungary, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety data | Safety data as measured by adverse device reactions | on ongoing basis up to 3 years | Yes |
Secondary | EuroQoL-5D | The EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension | baseline, 6, 12, 24, 36 months | No |
Secondary | MRI | Structural repair will be assessed by MRI. The available MRIs will be collected and scored by an independent radiologist, using the published MOCART score , and one additional item, level of the subchondral bone plate. | baseline, 12, 24, 36 months | No |
Secondary | Failure rate | Treatment failure is defined as "a re-intervention on the index lesion, prompted by persistence or recurrence of symptoms related to the index knee". The date of failure is the actual date of re-intervention. | 3 years | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects
|
Phase 2/Phase 3 |