Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01209390
Other study ID # OMCM-2010-01
Secondary ID
Status Terminated
Phase N/A
First received August 6, 2010
Last updated September 19, 2011
Start date September 2010
Est. completion date April 2016

Study information

Verified date September 2011
Source TiGenix n.v.
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Chondromimetic
The Chondromimetic implant is intended to serve as a scaffold for cellular and tissue ingrowth in osteochrondral defect repair such as bone and/or cartilage. The plug consists of a chondral layer with collagen and GAG and an osseus layer with collagen, GAG, and calcium phosphate.

Locations

Country Name City State
Belgium University Hospitals Leuven Leuven
Germany Universitätsklinikum Freiburg Freiburg
Hungary Uzsoki Hospital Budapest
United Kingdom Addenbrookes Hospital Cambridge

Sponsors (1)

Lead Sponsor Collaborator
TiGenix n.v.

Countries where clinical trial is conducted

Belgium,  Germany,  Hungary,  United Kingdom, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT00891501 - The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects Phase 2/Phase 3