Safety Study of PTP-001 for Treating Knee Osteoarthritis

Bioventus

Status and phase: Unknown; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Biological: Biological: PTP-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04632966

KOA-20-01

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 20 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

PTP-001 - Low Dose (100 mg)

Experimental group

Description:

intra-articular injection of 100 mg PTP-001 resuspended with 4 mL of normal saline

Treatment:

Biological: Biological: PTP-001

PTP-001 - High Dose (200 mg)

Experimental group

Description:

intra-articular injection of 200 mg PTP-001 resuspended with 4 mL of normal saline

Treatment:

Biological: Biological: PTP-001