Meniscal tear that would otherwise be treated by a partial meniscectomy.
Conditions
Interventions
Product Name: Cell Bandage
Pharmaceutical Form: Implant
Sponsors
Azellon Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The subject (or guardian, if appropriate) has signed and dated a specific informed consent form. 2. The subject agrees to provide a blood sample for testing of HIV-1, HIV-2, hepatitis B, hepatitis C, and syphilis. 3. The subject is between 18 and 35 years of age, inclusive. 4. The subject is able to comply with the protocol-defined preoperative procedures, the postoperative clinical and radiographic evaluations and the recommended rehabilitation regimen as determined by the investigator. 5. The subject has a diagnosis of a MRI confirmed (not older than 6 months), irreparable medial meniscus cartilage tear requiring surgical treatment 6. The meniscal tear should be a vertical tear in the red/white zone of the meniscus affecting the posterior horn or mid portion of the meniscus 7. The subject has no anterior cruciate ligament (ACL) deficiency in the involved knee. 8. Haemoglobin >9g/dL and platelet count >100,000/mm3 prior to Day 1 9. No contraindication to general anaesthetic 10. Female subjects of child-bearing potential: a negative urine pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has a history of total or partial medial or lateral menisectomy in the involved knee. 2. The subject has concomitant posterior cruciate ligament insufficiency of the involved knee or a concomitant injury that interferes with the subject’s ability to comply with the recommended rehabilitation program. 3. The subject has an ACL deficiency or previous ACL surgery. 4. The subject has a diagnosis of untreatable Grade IV (Outerbridge Classification) degenerative cartilage disease in the involved knee joint. 5. The subject has an uncorrected malformation or axial malalignment in the involved knee. 6. Patients demonstrating an active local or systemic infection (WBC > 15,000/mm3) 7. Any condition which in the judgment of the Investigator would preclude adequate evaluation of the CB and clinical outcome. 8. The subject has a history of anaphylactoid reaction. 9. The subject has an active systemic or local infection. 10. The subject has been tested positive for any of the following diseases: HIV (anti-HIV-1 or anti-HIV-2), Hepatitis B (HBs-Ag and anti-Hbc) and Hepatitis C (HCV-Ab), or syphilis (treponema pallidum; not RPR). 11. The patient does not wish to know the results of the screening HIV-1, HIV-2, hepatitis B, hepatitis C or syphilis blood tests 12. The subject has received systemic administration of any type of corticosteroid, antineoplastic, immunostimulating, or immuno-suppressive agents within 30 days prior to the scheduled bone marrow absorption or surgery. 13. The subject has evidence of osteonecrosis of the involved knee. 14. The subject has a medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis. 15. If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of the Cell Bandage when implanted into lesions in the white (avascular) region of the meniscus.;Secondary Objective: To perform observations relating to the efficacy of the implant, for the purpose of providing proof-of-concept of Cell Bandage. ;Primary end point(s): Safety: Preliminary safety data will be gathered with respect to the number, timing, severity, duration and resolution of related and non-related adverse events occurring among study subjects This includes incidence and severity of surgical complications such as the common known surgical complications associated with this type of surgical procedures; such as: chronic pain, arthrofibrosis, damage to the neurovasculature, osteonecrosis, postsurgical inflammation, infection, bleeding, and deep vein thrombosis. Other adverse events and significant changes in clinical parameters from baseline Clinical Outcome: Percentage of patients that have partial or full menisectomy during or after the initial procedure within the study follow-up period. ;Timepoint(s) of evaluation of this end point: Endpoint data will be obtained at the following timepoints: 1 week, 1, 3, 6 & 12 months, 2, 3, 4, 5, 6, 7 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Post-operative MRI compared to pre-implantation Pain compared to baseline Range of motion of the knee Pain medication;Timepoint(s) of evaluation of this end point: Post-operative MRI compared to pre-implantation - 3 & 6 months, 2 years post-implantation Pain compared to baseline - 3 & 6 months Range of motion of the knee - 3, 6 & 12 months, 2, 3, 4, 5, 6, 7 years Pain medication - 1, 3, 6 & 12 months, 2, 3, 4, 5, 6, 7 years | — |
Countries
United Kingdom
Contacts
Public ContactChief Operating Officer
Azellon Ltd
Outcome results
None listed