Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction

Exclusion Criteria

• •1. Uncontrolled alcohol, tobacco, or substance abuse within 6 months prior to implantation.
• •2. Mandibular ramus defects with open wounds.
• •3. Defects \> 15 cc in volume.
• •4. Defects \> 6 cm in diameter.
• •5. Systemic disease that would render the fat harvest and product implantation, along with associated anesthesia, unsafe to the patient.
• •6. Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would impact patient safety or interfere with the integrity of the study data.
• •7. Active uncontrolled infection or malignancy. Patients will be allowed to undergo rescreening once, after the infection is cleared, if they are willing to do so.
• •8. Patients with signs and symptoms of infection between Screening and up to the surgical implantation.
• •9. Radiation therapy \< 6 months prior to the surgical implantation.
• •10. Need for soft tissue reconstruction (flap, skin graft, etc).
• •11. Conditions that may impact the success of the surgical implantation or increase the risk of postoperative complications, including inherited coagulopathies like hemophilia, Von Willebrand's disease, protein C and S deficiency, thrombocythemias, thallassemias, sickle cell disease, etc.
• •12. Conditions that may impact functional outcomes, including uncontrolled diabetes, osteoporosis, rare disorders of bone healing like osteopetrosis, or any other metabolic bone disease.
• •13. Increased alkaline phosphatase (to exclude Paget's disease), increased serum calcium (to exclude hyperparathyroidism), or Vitamin D deficiency, at Screening, confirmed by a repeat test.
• •14. Oral bisphosphonate \< 12 weeks, intravenous bisphosphonate \< 12 months prior to Screening or use of systemic steroids or anabolic agents (e.g. teriparatide) for osteoporosis treatment.
• •15. Patients with inadequate donor sites for lipoaspirate of adipose tissue.
• •16. Mixed connective tissue diseases and collagen diseases which can result in poor wound healing after surgery.
• •17. Patients considered unsuitable per the consulted surgeon.
• •18. Patient has any of the following conditions as identified by medical history:
• •1. Human immunodeficiency virus (active or seropositive).
• •2. Active tuberculosis.
• •3. Active hepatitis B infection.
• •4. Hepatitis C.
• •5. Viral encephalitis.
• •6. Toxoplasmosis. In case of doubt regarding mentioned conditions based on the physical examination or other signs or symptoms present at Screening, the patient will be asked to consent to additional testing to rule out such conditions or the patient must be excluded from the study.
• •19. Donation of blood and blood products is not permitted from Screening and for at least 3 months after the surgical implantation.
• •20. Patient participated in another clinical study of an investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the surgical implantation or is currently participating in another clinical study of an investigational drug or intending to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.
• •21. Patients who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
• •22. The Investigator or any sub-investigator, research assistant, surgeon, study coordinator, or other staff directly involved in the conduct of the clinical study or any of their relatives.
• •23. Hypersensitivity to any product of bovine origin.
• •24. Hypersensitivity to gentamicin or other aminoglycosides.
• •25. Post-menopausal women who have an abnormally low bone mineral density or have not tested for bone mineral density.
• •26. Patients with discontinuity defects of the ramus.
• •27. Patients with a history of malignant cancer.
• •28. Hypersensitivity or allergy to epinephrine or other drugs commonly used during surgery.