NCT04632966

Safety Study of PTP-001 for Treating Knee Osteoarthritis

A Prospective, Open-Label, Dose-Escalation Phase 1 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bioventus LLC · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Biological: PTP-001	allogeneic placental tissue particulate

Timeline

• Start date: 2021-02-26
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2020-11-17
• Last updated: 2021-12-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study