E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Meniscal tear that would otherwise be treated by a partial meniscectomy. |
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E.1.1.1 | Medical condition in easily understood language |
A tear in the meniscus ("cartilage") in the knee that would otherwise be treated by surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety of the Cell Bandage when implanted into lesions in the white (avascular) region of the meniscus. |
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E.2.2 | Secondary objectives of the trial |
To perform observations relating to the efficacy of the implant, for the purpose of providing proof-of-concept of Cell Bandage. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | 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 |
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E.5.2 | Secondary end point(s) |
Post-operative MRI compared to pre-implantation
Pain compared to baseline
Range of motion of the knee
Pain medication |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |