260 Participants NeededMy employer runs this trial

PTP-001 for Knee Osteoarthritis

(MOTION Trial)

Recruiting at 15 trial locations
MK
Overseen ByMary Kathryn Kottke
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called PTP-001 (MOTYS™) for individuals with knee osteoarthritis. Researchers seek to determine if a single injection of PTP-001 can reduce pain and improve knee function compared to a placebo, a harmless substance used for comparison. Those who have experienced knee osteoarthritis for at least six months, with the condition as their primary source of pain, and who haven't found relief with standard pain medications, might be suitable candidates for this trial. Participants must be willing to follow the study guidelines and attend scheduled check-ups. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to access a potentially effective treatment early.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any unauthorized medications for osteoarthritis or other conditions during the study. You can only use acetaminophen for knee pain as needed.

Is there any evidence suggesting that PTP-001 is likely to be safe for humans?

Research has shown that PTP-001 (MOTYS™) is generally safe for treating knee osteoarthritis. Studies found that PTP-001 did not cause any major health problems. Participants in these studies demonstrated that the treatment is well-tolerated, meaning it does not cause significant side effects. Safety data from these trials remained within normal limits, suggesting the treatment does not pose unexpected risks. Overall, evidence indicates that PTP-001 is a promising and safe option for people with knee osteoarthritis.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for knee osteoarthritis, which often involve oral medications like NSAIDs or physical therapy, PTP-001 (MOTYS™) is an innovative approach because it's a single intra-articular injection directly into the knee. This targeted delivery method could potentially provide more direct relief to affected areas with fewer systemic side effects. Researchers are excited about PTP-001 because it offers the possibility of pain relief and improved joint function with just one injection, which could be a game-changer for patients seeking quick and sustained relief.

What evidence suggests that PTP-001 might be an effective treatment for knee osteoarthritis?

Research has shown that PTP-001 (MOTYS™) might help with knee osteoarthritis. In one study, 69.5% of participants who received PTP-001 experienced significant pain relief and improved movement after 26 weeks. In animal studies, PTP-001 reduced pain for six weeks following treatment. This trial will compare PTP-001 to a placebo to evaluate its effectiveness in reducing knee pain and improving movement in people with osteoarthritis.16789

Who Is on the Research Team?

PD

Professor David Hunter

Principal Investigator

Chair of Rheumatology at University of Sydney and Royal North Shore Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 with mild to moderate knee osteoarthritis causing their main pain, who have had symptoms for at least 6 months and haven't responded well to common painkillers. People with severe obesity, recent major knee injuries or surgeries, certain other health conditions, or significant pain elsewhere can't join.

Inclusion Criteria

My knee osteoarthritis symptoms started at least 6 months ago.
Willing to comply with study visit schedule and post-injection restrictions
Written informed consent is obtained from the participant
See 8 more

Exclusion Criteria

Clinically severe obesity as defined by the National Institutes of Health (body mass index ≥ 40 kg/m2) at Screening and / or Baseline
I have had radiation therapy on my target knee.
Severe (excessive) malalignment of the tibial-femoral axis assessed radiographically
See 26 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single intra-articular injection of either PTP-001 or placebo

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PTP-001 (MOTYS™)

Trial Overview

The study tests a single injection of PTP-001 (MOTYS) into the knee versus a placebo (saline), to see if it helps reduce osteoarthritis symptoms over one year. Participants are randomly assigned and neither they nor doctors know which treatment they get.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PTP-001 200 mgExperimental Treatment1 Intervention
Group II: Placebo / saline vehiclePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Doron Therapeutics Inc.

Lead Sponsor

Novotech (Australia) Pty Limited

Industry Sponsor

Trials
76
Recruited
7,800+

Dr. John Moller

Novotech (Australia) Pty Limited

Chief Executive Officer

MD and MBA from the University of Oxford

Dr. Judith Ng-Cashin

Novotech (Australia) Pty Limited

Chief Medical Officer since 2023

MD

Citations

Safety Study of PTP-001 for Treating Knee Osteoarthritis

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, ...

Efficacy and safety of an intra-articular placental tissue ...

Therefore, this trial aimed to determine the effect of diacerein on knee pain and effusion-synovitis over 24 weeks in patients with symptomatic knee OA and MRI- ...

A novel placental tissue biologic, PTP-001, inhibits ...

In a rat osteoarthritis model, PTP-001 significantly reduced pain responses throughout 6 weeks post-dosing. The magnitude and duration of pain reduction ...

A Study to Evaluate the Efficacy and Safey of PTP-001 ...

The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to ...

Intra-Articular Placental Tissue Product Shows Benefits in ...

In the per-protocol population, 69.5% of participants receiving PTP-001 200 mg achieved a strict OMERACT-OARSI response at week 26, compared ...

Efficacy and safety of an intra-articular placental tissue ...

065 - Efficacy and safety of an intra-articular placental tissue particulate (MOTYS/PTP-001) in symptomatic knee osteoarthritis over 26 weeks: A placebo ...

Safety And Efficacy Results From A Phase 1 Clinical Trial ...

Conclusions: PTP-001 represents a safe and potentially efficacious treatment for painful knee OA which warrants further study. Data from this Phase 1 study, as ...

A Study to Evaluate the Efficacy and Safey of PTP-001 ...

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- ...

NCT05100225 | Efficacy and Safety Trial of PTP-001 ...

Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in ...