safety study of ptp-001 for treating knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: evaluation of safety, tolerability, and efficacy of a single intra-articular (ia) injection of ptp-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (oa).

this open-label, dose-escalation study is expected to enroll 20 participants, 40-80 years of age and test two doses (low and high dose) of ptp-001, an allogeneic placental tissue particulate, in two unique cohorts of 10 participants each. each participant will receive a single intra-articular (ia) injection of ptp-001. following the completion of the first cohort in which 10 participants (kellgren-lawrence grade 2 or 3 knee oa) will be treated with the low dose of ptp-001, safety data will be reviewed by an independent data and safety monitoring board (dsmb).

Eligibility criteria:
inclusion criteria: * written consent to participate in the study * male or female, aged 40 to 80 years * symptomatic knee oa with kellgren-lawrence radiographic classification of 2 or 3 * non-responsive after at least 3 months of conservative therapy for knee oa * females of childbearing potential must have negative pregnancy test result prior to treatment and must commit to highly effective methods of contraception for at least 6 months after treatment * willingness to report oral analgesic treatment used for knee pain and to discontinue analgesic treatment for knee pain in 24 hours prior to each study visit * willingness to limit use of pain rescue medication to oral acetaminophen for management of painful knee oa flare exclusion criteria: * body mass index (bmi) ≥ 40 kg/m2 or bmi ≥ 35 kg/m2 with condition that warrants weight loss surgery * presence of active infection of index knee or systemic infection requiring treatment within 3 months of screening * administration of ia injection within 3 months of screening * significant acute injury to index knee within 3 months of screening * surgery to index knee within 6 months of screening or planned surgery to index knee within 6 months after screening * unstable index knee joint * history of radiation therapy of index knee * known vascular or neurological disorder affecting the index knee * osteonecrosis of either knee * clinical diagnosis of inflammatory arthritis * clinical diagnosis of autoimmune disease affecting the musculoskeletal system * use of any other investigational therapy within 3 months of screening or planned for the duration of the study * current anti-coagulant use * history of receiving a solid organ or hematologic transplant * history of malignancy or radiotherapy within 5 years of screening, except for basal or squamous cell carcinoma of the skin * use of immunosuppressive or chemotherapeutic agents within 5 years of screening * known allergy to local anesthetics or allograft tissues * known history of hepatitis * known history of thrombotic or thromboembolic phenomena. * known history of primary or secondary immunodeficiency disorders * presence of concurrent medical condition that, in the investigator's judgement, could compromise participant safety or interfere with the required study assessments and study participation. note: other protocol defined inclusion/exclusion criteria apply.