A clinical trial to test the safety of Cell Bandage, a product made from the patient's own bone marrow stem cells, in the treatment of meniscus (cartilage) tears in the knee
- Conditions
- Meniscal tear that would otherwise be treated by a partial meniscectomy.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2010-024162-22-GB
- Lead Sponsor
- Azellon Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method