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

NCT ID
NCT07219771
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Doron Therapeutics Inc.
Conditions
Knee Osteoarthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 3 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis

Enrollment: 300 participants (Estimated).

What is being studied

  • Intervention: Chlorides
  • Intervention: Chlorine Compounds
  • Intervention: Crystalloid Solutions
  • Intervention: Hydrochloric Acid
  • Intervention: Inorganic Chemicals
  • Intervention: Isotonic Solutions
  • Intervention: Pharmaceutical Preparations
  • Other: Placebo control / saline vehicle
  • Biological: PTP-01
  • Intervention: Saline Solution
  • Intervention: Sodium Chloride
  • Intervention: Sodium Compounds
  • Intervention: Solutions

Who may be eligible

Ages
40 Years to 80 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Males and females aged 40 to 80 years. 2. Presenting with symptomatic knee OA with Kellgren-Lawrence (KL) radiographic classification of 2 or 3 (mild or moderate), as assessed by the central reading facility. 3. Primary source of pain throughout the body is due to OA in the target knee. 4. Target knee pain ≥ 20 and ≤ 40 out of 50 on the WOMAC® numerical rating scale (NRS) 3.1 pain questionnaire (sum of 5 questions) at Screening and Baseline. 5. Onset of symptomatic OA of the target knee was at least 6 months prior to Screening. 6. Insufficient, failed response, or intolerance to analgesics and / or non-steroidal anti-inflammatory drugs (NSAIDs), as reported by the participant. 7. If female, must meet all of the following: 1. Not breast feeding, 2. Not planning to become pregnant during the study, 3. Must abstain from ova / egg donation during the study, 4. If of childbearing potential, must have a negative pregnancy test result within 72 hours prior to receiving the intra-articular injection, and must commit to the use of a highly effective form of birth control for at least 90 days after the injection. 8. Willing to use acetaminophen as the only oral rescue (as needed) analgesic medication for target knee pain during the study. 9. Willing to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study. 10. Willing to comply with study visit schedule and post-injection restrictions. 11. Written informed consent is obtained from the participant. Exclusion Criteria: 1. Participant is non-ambulatory (unable to walk \> 50 feet / 15 meters without assistance). 2. Clinically severe obesity as defined by the National Institutes of Health (body mass index ≥ 40 kg/m2) at Screening and / or Baseline. 3. Contralateral (non-target) knee pain is \>10 out of 50 on the WOMAC® NRS 3.1 pain questionnaire (sum of 5 questions) at Screening or at Baseline. 4. At Baseline, difference between the first Baseline and second Baseline WOMAC pain scores is \> 3 for the target knee. 5. Contralateral (non-target) knee pain is experienced for ≥ 14 days in the month. 6. Use of any analgesia during the washout period (5 half-lives) at Screening or Baseline. 7. Participation in any investigational study within 30 days (or 5 half-lives, whichever is longer) prior to Screening or planning to participate in any other investigational drug or device clinical trials within 30 days of study completion. 8. Currently requires use of a lower extremity prosthesis and / or a structural knee brace (ie, a knee brace that contains hardware). 9. Clinically significant effusion of the target knee at either the Screening or Baseline visits as determined by physical examination (eg, ballotable patella or positive bulge sign). Note: Participants presenting with effusion may be enrolled in the study after undergoing knee aspiration to remove excess fluid in the target joint. 10. Clinical and/or radiographic evidence (other than that performed for Kellgren-Lawrence eligibility assessment) of severe (excessive) malalignment of the tibial-femoral axis, as assessed by the Investigator. 11. Presence of active infection in the target knee or systemic infection requiring treatment within the 3 months prior to Screening. 12. Clinical diagnosis of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology. 13. Participant is receiving, has received, or plans to receive any of the following therapies: 1. Prior administration of hyaluronic acid, extended-release corticosteroid (eg, Zilretta®), platelet-rich plasma (PRP), or stem cell therapies by intra-articular injection(s) of the target knee within 6 months prior to Screening. 2. Prior administration of corticosteroid by intra-articular injection of the target knee within 3 months prior to Screening or into any other joint within 30 days prior to Screening. 3. Current chronic systemic use of corticosteroids in doses exceeding the equivalent of 10 mg prednisolone daily. 4. Treatment with any investigational therapy (drug, device, or biologic) within 3 months prior to Screening or is planned for the duration of the study. 5. Treatment with immunosuppressive medication (not including mild transient immunosuppressants such as corticosteroids) or chemotherapy within the past 5 years. 14. Chronic use of narcotics or alcohol abuse within the past 6 months prior to Screening. 15. Surgery to either knee (including arthroscopy) within 6 months prior to receiving the intra-articular injection or planned surgery of either knee within 6 months after the injection. 16. Participant previously underwent arthroplasty (ie, full or partial knee replacement) of the target knee. 17. Presence of joint instability or complaints of locking, intermittent limitation in range of motion, or loose body sensation, suggestive of internal derangement of the knee (either extremity). 18. Diagnosis of lower extremity gout or pseudo-gout in the past 6 months prior to Screening. 19. History of, or current manifestation of, osteonecrosis of either knee. 20. Significant acute (within the past 3 months) injury to the target knee. 21. History of receiving a solid organ or hematologic transplant. 22. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin. 23. History of prior radiation therapy of the target knee. 24. History of autoimmune disease affecting the musculoskeletal system. 25. Known (documented) history of acquired immune deficiency syndrome or human immunodeficiency virus (HIV). 26. Any condition causing pain in or around the target knee (eg, radiating pain or pain in another region of the ipsilateral lower extremity) that may interfere with assessment(s) of the target knee. 27. Other chronic pain anywhere in the body that requires the chronic use of analgesic medications, such as knee OA of the contralateral (non-target) knee, fibromyalgia, tendonitis, plantar fasciitis, neuropathic pain, lower back pain, etc. 28. Known presence of any concurrent medical condition (eg, hematologic renal, hepatic, cardiac, or coagulation abnormalities) or other factors that in the Investigator's judgment would interfere with the required study assessments and study participation. 29. Participant is involved in litigation (eg, worker's compensation) for a medical condition or injury at any anatomical site.

Study locations

18 study locations are listed.

Recruiting site status is explicitly provided for 18 locations; 11 are listed as Recruiting.

Countries: Australia, United States

  • New South Wales, Australia: 3
  • Queensland, Australia: 5
  • Victoria, Australia: 1
  • Alabama, United States: 1
  • Arizona, United States: 1
  • California, United States: 2
  • Florida, United States: 1
  • Illinois, United States: 1
  • Pennsylvania, United States: 1
  • South Carolina, United States: 1
  • Utah, United States: 1

Sample of listed locations

  • Genesis Research Services — Broadmeadow, New South Wales, 2292, Australia — Recruiting
  • University of the Sunshine Coast Clinical Trials, Maroochydore — Maroochydore, Queensland, 4566, Australia — Recruiting
  • Momentum Clinical Research Sunshine — St Albans, Victoria, 3021, Australia — Recruiting
  • Central Research Associates, LLC dba Flourish Research — Birmingham, Alabama, 35205, United States — Recruiting
  • Tucson Orthopaedic Institute — Tucson, Arizona, 85712, United States — Recruiting
  • Horizon Clinical Research — La Mesa, California, 91942, United States — Recruiting
  • Focus Clinical Research — West Hills, California, 91307, United States — Recruiting
  • Conquest Research, LLC — Winter Park, Florida, 32789, United States — Recruiting
  • Chicago Clinical Research Institute, Inc. — Chicago, Illinois, 60607, United States — Recruiting
  • Coastal Carolina Research Center, LLD — North Charleston, South Carolina, 29405, United States — Recruiting
  • JBR Clinical Research, LLC — Salt Lake City, Utah, 84107, United States — Recruiting
  • Emeritus Research Sydney — Botany, New South Wales, 2019, Australia — Terminated
  • Royal North Shore Hospital — St Leonards, New South Wales, 2065, Australia — Active, not recruiting
  • University of the Sunshine Coast Clinical Trials, Birtinya — Birtinya, Queensland, 4575, Australia — Active, not recruiting
  • University of the Sunshine Coast Clinical Trials, Morayfield — Morayfield, Queensland, 4506, Australia — Active, not recruiting
  • Momentum Clinical Research Taringa — Taringa, Queensland, 4068, Australia — Active, not recruiting
  • Momentum Clinical Research Wellers Hill — Tarragindi, Queensland, 4121, Australia — Terminated
  • Lehigh Center for Clinical Research — Allentown, Pennsylvania, 18104, United States — Withdrawn

Study details

Start date
October 14, 2025
Primary completion date
June 30, 2027
Completion date
December 30, 2027
First posted
October 22, 2025
Collaborators
Novotech (Australia) Pty Limited

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07219771
Registry last updated
October 16, 2026
QualifiedStudies registry data refreshed
October 19, 2026
QualifiedStudies record fetched
October 19, 2026

View NCT07219771 on ClinicalTrials.gov

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