drugset / Trial / NCT05100225
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2021-09-30
- Primary completion
- 2022-10-31
- Completion
- 2022-11-30
Publications
- 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.
- James JJ, Pahal S, Jayaraman A, Nayak A D, Koteshwar Narasimhachar S, Sundarrajan S, Basappa Veerabhadraiah B, Srinivasan B, Vemula PK, Nguyen TD, Kadamboor Veethil S. Polymeric Microneedles for Transdermal Delivery of Human Placental Tissue for the Treatment of Osteoarthritis. Macromol Biosci. 2025 Mar;25(3):e2400485. doi: 10.1002/mabi.202400485. Epub 2024 Dec 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PTP-001 | Protein / enzyme biologic | 100 mg | Other |
| Subject | PTP-001 | Protein / enzyme biologic | 200 mg | Other |