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A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients

NCT07219771 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-04-29

No results posted yet for this study

Summary

This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis.

The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to placebo over a 52-week period in participants with radiographic and symptomatic knee OA.

Conditions

Interventions

BIOLOGICAL

PTP-01

Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.

OTHER

Placebo control / saline vehicle

The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Doron Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Professor David Hunter · Chair of Rheumatology at University of Sydney and Royal North Shore Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2027-04-30
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07219771 on ClinicalTrials.gov