Safety Study of PTP-001 for Treating Knee Osteoarthritis

NCT ID: NCT04632966

Last Updated: 2021-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2022-12-31

Brief 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).

Detailed 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).

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PTP-001 - Low Dose (100 mg)

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

Group Type: EXPERIMENTAL

Biological: PTP-001

Intervention Type: BIOLOGICAL

allogeneic placental tissue particulate

PTP-001 - High Dose (200 mg)

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

Group Type: EXPERIMENTAL

Biological: PTP-001

Intervention Type: BIOLOGICAL

allogeneic placental tissue particulate

Interventions

Biological: PTP-001

allogeneic placental tissue particulate

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioventus LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annunziato Amendola, MD

Role: PRINCIPAL_INVESTIGATOR

James R. Urbaniak, MD, Duke Sports Science Institute

Locations

James R. Urbaniak, MD, Duke Sports Science Institute

Durham, North Carolina, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Countries

United States

References

Flannery CR, Seaman SA, Buddin KE, et al. Characterization and preclinical efficacy of PTP-001, a novel human tissue biologic in development for the treatment of OA. Osteoarthritis Cartilage. 2020 Apr;28(Supplement 1):S487-S489. doi: 10.1016/j.joca.2020.02.763

Reference Type: BACKGROUND

Flannery CR, Seaman SA, Buddin KE, Nasert MA, Semler EJ, Kelley KL, Long M, Favret J, Pavesio A, Loeser RF. A novel placental tissue biologic, PTP-001, inhibits inflammatory and catabolic responses in vitro and prevents pain and cartilage degeneration in a rat model of osteoarthritis. Osteoarthritis Cartilage. 2021 Aug;29(8):1203-1212. doi: 10.1016/j.joca.2021.03.022. Epub 2021 May 20.

Reference Type: BACKGROUND

PMID: 34023528 (View on PubMed)

Other Identifiers

KOA-20-01

Identifier Type: -

Identifier Source: org_study_id