ReNu™ Injection to Treat Hip Osteoarthritis Study

This is a prospective, non-randomized pilot study evaluating the efficacy of ReNu™ hip
injection on patients with moderate osteoarthritis. The effects will be measured primarily
through patient-reported outcomes questionnaires after a single injection. Patients will be
followed up to 12 months to evaluate improvements using common pain and function subscales.

Inclusion Criteria:

- Patients with moderate hip osteoarthritis determined by a combination of clinical and
radiographic findings

- Radiographic findings consistent with osteoarthritis as documented by Tonnis
radiographic classification (Grade 1 or 2)

- Grade 1 Tonnis changes are defined as mild and include increased sclerosis, slight
narrowing of the joint space, no or slight loss of head sphericity

- Grade 2 Tonnis changes are defined as moderate and include small cysts, moderate
narrowing of the joint space, moderate loss of head sphericity

- Patients with bilateral grade 1or 2 Tonnis hip osteoarthritis who have bilateral
symptoms may have their more symptomatic hip injected. If equivalent symptoms are
reported by the patient, then the patient will choose which hip is to be injected. The
other Hip can be treated with all standard local interventions that will not have a
prolonged systemic effect that could affect the study hip (for example steroid
injection, cold therapy, soft braces).

- Between the Ages 18 to 70 with minimum activity level of 2 on the Tegner scale.

- BMI less than 40

- Female patients must be actively practicing a contraception method, abstinence, be
surgically sterilized, or be postmenopausal

Exclusion Criteria:

- Pain medication (including NSAIDs) less than 15 days before injection (may take
acetaminophen)

- Receiving pain medication other than acetaminophen for conditions unrelated to
osteoarthritis of the index hip

- Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of
antiplatelet medications are not a reason for exclusion

- History of substance abuse.

- Failure to agree NOT to take additional hip symptom modifying drugs, other than
acetaminophen, during the course of the study without reporting to the study team

- Pregnancy or desire to become pregnant during study duration

- Corticosteroid injection into the index hip within 6 months

- Viscosupplement injection into the index hip within 6 months

- Previous open or arthroscopic hip surgery of the involved index hip within the
previous 6 months

- Open or arthroscopic surgery of the contralateral hip within the last 6 months

- Worker compensation

- Acute index hip injury (injury within 3 months)

- History of Diabetes mellitus

- History of solid organ or hematologic transplantation

- History of rheumatoid arthritis or other autoimmune disorder

- Diagnosis of a non-basal cell malignancy within the preceding 5 years

- Infection requiring antibiotic treatment within the preceding 3 months

- Current therapy with any immunosuppressive medication, including corticosteroids at a
dose > 5 mg per day