Actively Recruiting

Phase 3
Age: 40Years - 80Years
All Genders
ID07219771

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Intra-Articular Administration of PTP-001 for Knee Osteoarthritis

Led by Doron Therapeutics Inc. · Updated on 2026-04-29

260

Participants Needed

17

Research Sites

26 weeks

Total Duration

On this page

Sponsors

D

Doron Therapeutics Inc.

Lead Sponsor

N

Novotech (Australia) Pty Limited

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of PTP-001 (MOTYS), an allogeneic human placental tissue particulate, for treating knee osteoarthritis (OA). This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the safety, tolerability, and effectiveness of a single injection of PTP-001 compared to placebo over a 52-week period in adults aged 40 to 80 with symptomatic and radiographically confirmed knee OA. Participants will be randomly assigned to receive one injection into the target knee of either 200 mg PTP-001 or 4 mL of placebo saline solution. The study includes a screening period lasting up to 28 days before treatment, a one-day treatment phase when the injection occurs, and a follow-up phase of 12 months to monitor outcomes and safety. Approximately 260 participants will be enrolled, with 130 in each treatment group. During the study, participants will undergo assessments at multiple time points, including evaluations of knee pain and function using standardized scales such as WOMAC and patient global assessments. The main outcomes focus on the proportion of participants showing strict improvement in knee pain and function at 6 months, with additional measurements at 9 and 12 months. Safety and tolerability will also be monitored throughout the follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 40 to 80 years
  • Symptomatic knee osteoarthritis with mild or moderate radiographic severity (Kellgren-Lawrence grade 2 or 3)
  • Main source of pain is knee osteoarthritis in the target knee
  • Target knee pain score between 20 and 40 out of 50 on WOMAC pain scale at screening and baseline
  • Symptoms in the target knee present for at least 6 months before screening
  • Insufficient response, intolerance, or failure of analgesics or NSAIDs
  • If female of childbearing potential, must not be breastfeeding, must not plan pregnancy, must abstain from egg donation, have negative pregnancy test before injection, and use effective birth control for 90 days after injection
  • Willing to use acetaminophen only as rescue medication for knee pain during study
  • Willing to avoid unauthorized medications for osteoarthritis or other conditions during study
  • Willing to follow study visit schedule and post-injection restrictions
  • Provide written informed consent
Not Eligible

You will not qualify if you...

  • Unable to walk more than 50 feet without assistance
  • Severe obesity with body mass index 40 kg/m2 or higher
  • Contralateral knee pain score 10 or higher on WOMAC pain scale at screening or baseline
  • Large difference (3 points or more) between baseline pain scores for target knee
  • Contralateral knee pain lasting 14 or more days in the month
  • Use of analgesics during washout period prior to screening or baseline
  • Participation in other investigational studies within 30 days before screening or planned participation within 30 days after study completion
  • Current use of lower extremity prosthesis or structural knee brace with hardware
  • Significant fluid buildup (effusion) in target knee unless drained before enrollment
  • Severe malalignment of knee joint
  • Active infection in target knee or systemic infection requiring treatment within 3 months prior to screening
  • Diagnosed inflammatory arthritis such as rheumatoid arthritis or lupus
  • Prior intra-articular injections (hyaluronic acid, corticosteroids, PRP, stem cells) within specified time frames
  • Chronic systemic corticosteroid use exceeding equivalent of 10 mg prednisolone daily
  • Immunosuppressive medication or chemotherapy within past 5 years
  • Chronic narcotic use or alcohol abuse within past 6 months
  • Recent surgery to either knee within 6 months before or planned within 6 months after injection
  • Previous knee replacement of target knee
  • Joint instability or symptoms suggesting internal knee problems
  • Diagnosis of gout or pseudo-gout within past 6 months
  • History or current osteonecrosis of either knee
  • Recent acute injury to target knee within 3 months
  • History of organ or hematologic transplant
  • History of cancer treatment within past 5 years except certain skin cancers
  • Prior radiation therapy of target knee
  • Autoimmune diseases affecting muscles or joints
  • Known HIV/AIDS
  • Other conditions causing pain around the target knee that could interfere with assessments
  • Other chronic pain conditions requiring chronic analgesics
  • Medical conditions that could interfere with study participation
  • Involvement in litigation related to medical conditions or injury

AI-Screening

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Your Study Journey

Screening

Duration - Up to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Treatment

Duration - 1 day

Participants receive a single intra-articular injection of either PTP-001 or placebo in the target knee on Day 1.

1 treatment visit (in-person)

Follow-up

Duration - 12 months

Participants are monitored for safety and efficacy outcomes over 12 months following treatment.

Scheduled follow-up visits over 12 months to assess knee function and pain

Trial Site Locations

Total: 17 locations

1

Central Research Associates, LLC dba Flourish Research

Birmingham, Alabama, United States, 35205

Actively Recruiting

2

Horizon Clinical Research

La Mesa, California, United States, 91942

Actively Recruiting

3

Focus Clinical Research

West Hills, California, United States, 91307

Actively Recruiting

4

Conquest Research, LLC

Winter Park, Florida, United States, 32789

Actively Recruiting

5

Chicago Clinical Research Institute, Inc.

Chicago, Illinois, United States, 60607

Actively Recruiting

6

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States, 18104

Actively Recruiting

7

Coastal Carolina Research Center, LLD

North Charleston, South Carolina, United States, 29405

Actively Recruiting

8

JBR Clinical Research, LLC

Salt Lake City, Utah, United States, 84107

Actively Recruiting

9

Emeritus Research Sydney

Botany, New South Wales, Australia, 2019

Actively Recruiting

10

Genesis Research Services

Broadmeadow, New South Wales, Australia, 2292

Actively Recruiting

11

Royal North Shore Hospital

St Leonards, New South Wales, Australia, 2065

Actively Recruiting

12

University of the Sunshine Coast Clinical Trials, Birtinya

Birtinya, Queensland, Australia, 4575

Actively Recruiting

13

University of the Sunshine Coast Clinical Trials, Morayfield

Morayfield, Queensland, Australia, 4506

Actively Recruiting

14

University of the Sunshine Coast Clinical Trials, Noosa

Noosaville, Queensland, Australia, 4566

Actively Recruiting

15

Momentum Clinical Research Taringa

Taringa, Queensland, Australia, 4068

Actively Recruiting

16

Momentum Clinical Research Wellers Hill

Tarragindi, Queensland, Australia, 4121

Terminated

17

Momentum Clinical Research Sunshine

St Albans, Victoria, Australia, 3021

Actively Recruiting

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Research Team

M

Mary Kathryn Kottke

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Composition and Bioactivity of a Placental Tissue Particulate (PTP-001) Indicate Greater Potential than Platelet-Rich Plasma for the Treatment of Osteoarthritis.

Carl R Flannery, Kelly E Buddin, Laila Begum...

https://pubmed.ncbi.nlm.nih.gov/36912174

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.

C R Flannery, S A Seaman, K E Buddin...

https://pubmed.ncbi.nlm.nih.gov/34023528