Trial Reference Card Clinical Study Clinical Study Clinical Study Protocol No. 8-01 Protocol No. 8-01 Protocol No. 8-01IRB Approval Required INCLUSION CRITERIA PRE-PROCEDURE EXCLUSION CRITERIA (cont.) ARTHROSCOPY INCLUSION CRITERIA 1. Able and willing to give informed consent. 13. Any autoimmune disease. 1. At least one ICRS grade 3 or 4A lesion located on either the medial or 14. HIV, chronic hepatitis B or C viral infection. lateral femoral condyle that would be treatable by microfracture. ICRS 2. 18 years to 55 years of age. 15. Insulin-dependent diabetes. grade 4A lesions must have no substantive bone loss. 16. Clinically significant or symptomatic vascular or neurologic disorder of 3. Symptomatic with knee pain indicative of an articular cartilage injury of 2. One or two non-contiguous and non-opposing lesions may be treated as the distal femur. Baseline KOOS pain score must be < 80, Baseline IKDC the lower extremities. long as each lesion meets the arthroscopic inclusion and exclusion Subjective score must be < 70. 17. Current drug or alcohol abuse. criteria and the total surface area of both treated lesions is < 6 cm2 (size 18. Ligament reconstruction on either knee within six months prior to study of NeoCart®). With respect to the individual lesion size, each treated 4. Medically able to undergo arthroscopy, arthrotomy, and serial MRIs. lesion must be at least 1 cm in one linear dimension. The range of lesion arthroscopy. sizes treated shall be between 0.5 cm2 - 6 cm2. PRE-PROCEDURE EXCLUSION CRITERIA 19. Evidence suggesting inability to comply with the Protocol. 20. Smoking habit of more than 1 pack of cigarettes per week and/or are ARTHROSCOPY EXCLUSION CRITERIA 1. Any previous surgical treatment of the study defect. (such as Microfracture). Prior debridement of the study lesion is permitted but frequent users (>1/week) of chewing tobacco. The number of smokers 1. Subchondral bone loss. must have been performed >3 months prior to the study arthroscopy. will be limited to 10% of the enrolled subjects. 21. Any concomitant painful or disabling disease of the hips or lower limbs 2. Untreated ACL and/or PCL deficiency or ligamentous instability in the 2. Body Mass Index (BMI) > 35 kg/m2. that would interfere with the evaluation of the afflicted knee. index knee. 22. Treatment with specific osteoarthritis drugs, such as chondroitin sulfate, 3. Radiographic evidence of osteoarthritis, Kellgren Lawrence Grade 3 or diacerein, n-glucosamine, piascledine, and capsaicin, within the last two 3. Study lesion requiring a concomitant procedure intended as a greater. weeks. therapeutic intervention to the study lesion, e.g. - debridement/ 23. Corticosteroid therapy by systemic or intra-articular route within the last chondroplasty, or that may alter the mechanics of the joint, e.g. - 4. Malalignment greater than 3 degrees outside the mechanical axis from month of baseline or intramuscular or oral corticosteroids within the last osteotomy. Permitted concomitant procedures include: other knee, or malalignment requiring surgical correction. two weeks. • Medial or lateral partial meniscectomy of less than 50% radial width, 24. Intra-articular injections of hyaluronic acid into the afflicted knee within preserving a fully intact peripheral rim; 5. Symptomatic pathology of the contralateral knee. the last six months. • Removal of loose bodies or impending loose bodies; 25. Status as a participant in an investigational research trial within the last • Debridement/chondroplasty of non-study lesions; 6. Surgery on the contralateral knee within the 3 months prior to the study three months. • Synovectomy; arthroscopy. • Judicious excision of tissue from the study lesion(s) to the extent HISTOGENICS CORPORATION necessary to facilitate measurement and grading of the lesion(s) in 7. Any form of inflammatory arthritis. NeoCart® Trial Protocol 8-01 April 15, 2014 order to complete the final qualification step prior to randomization. 8. Ankylosing spondylitis. 4. Meniscus whose rim is less than 50% of normal radial width or whose peripheral rim is not fully intact. 9. Synovioma, hemangioma, pigmented villonodular synovitis (PVNS), or other neoplasms in the knee. 5. ICRS Grade 3 or 4 kissing lesions. 10. Any condition requiring chemotherapy. 6. ICRS Grade 3B or greater patella, trochlea or tibial lesions, the size of which exceeds the area of the study lesion(s) and/or is associated with 11. Positive pregnancy test or intention to become pregnant during the year pain specifically and reproducibly referable to the untreated lesions(s). following treatment. 12. Known history of allergy to bovine products or gentamycin. continued next column
PortalIRB Approval Required
NeoCart Contact Center Contact Center Phone: 1-855-9-NEOCARTHours of Operation: Mon-Fri 8:30am – 8:00pm Eastern Standard Time (EST) Email: [email protected] Sepp Kathleen LargeClinical Program Director Vice President, Clinical [email protected] [email protected]: 617-395-9520 O: 781-547-7907M: 617-710-0770 M: 617-501-8566www.NeoCartImplant.com
NeoCart Contact Center Contact Center Phone: 1-855-9-NEOCARTHours of Operation: Mon-Fri 8:30am – 8:00pm Eastern Standard Time (EST) Email: [email protected] www.NeoCartImplant.com
ConferencesObjective: To create an awareness of theNeoCart Clinical Trial.
Sawbones Model
Poster w/ Easel (24” x 36”)
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