Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis

Exclusion Criteria

• •1. Subject has undergone previous corticosteroid injection therapy to the effected elbow in less than three months prior to enrollment
• •2. Subject has received previous Platelet Rich Plasma (PRP) injection to the affected elbow
• •3. Subject is deemed to require a corticosteroid injection into the affected elbow during the course of the study
• •4. Subject uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage \>10mg/day)
• •5. Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis
• •6. Subject has a positive medical history of any of the following:
• •1. medial epicondylitis
• •2. radial tunnel syndrome
• •3. carpal tunnel syndrome
• •4. septic or gouty arthritis
• •5. cervical radiculopathy
• •6. trauma to the affected elbow within the past 6 weeks
• •7. neuromuscular or musculoskeletal deficiency, which limits the ability to perform functional measurement (e.g. grip strength test)
• •7. Subject currently has an acute infection at the injection site
• •8. Subject has tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or are currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed rhPDGF-BB Injection treatment site
• •9. Subject is physically or mentally compromised (e.g. currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant
• •10. Subject has an allergy to yeast-derived products
• •11. Subject has received an investigational therapy or approved therapy for investigational use within 30 days of injection procedure or during the follow-up phase of this study
• •12. Subject is a prisoner, or is known or suspected to be transient
• •13. Subject's condition represents a worker's compensation case
• •14. Subject is currently involved in a health-related litigation procedure
• •15. Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to screening for study entry
• •16. Subject is pregnant, or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period