Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a placenta injection ease your knee pain?

NCT ID NCT07219771

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a single injection of particles from donated placental tissue (PTP-001) can reduce pain and improve function in people with knee osteoarthritis. About 260 adults aged 40–80 with mild-to-moderate knee OA will receive either the placental injection or a placebo (saline). The study lasts 52 weeks and measures changes in pain and daily activities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
placental tissue particles (PTP-001, also called MOTYS)
What this could lead to
If it works, this could provide a new, non-surgical option to reduce pain and improve knee function for people with mild-to-moderate knee osteoarthritis.
What could go wrong
This is still an experimental treatment, and it's being compared to a placebo (saline injection). Even if effective, it may only help some people and not cure the underlying arthritis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Severe (excessive) malalignment of the tibial-femoral axis assessed radiographically (by previous X-ray, rather than that performed for Kellgren-Lawrence assessment). 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Knee osteoarthritis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Central Research Associates, LLC dba Flourish Research

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • Chicago Clinical Research Institute, Inc.

    RECRUITING

    Chicago, Illinois, 60607, United States

  • Coastal Carolina Research Center, LLD

    RECRUITING

    North Charleston, South Carolina, 29405, United States

    Contact Email: •••••@•••••

  • Conquest Research, LLC

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Emeritus Research Sydney

    RECRUITING

    Botany, New South Wales, 2019, Australia

  • Focus Clinical Research

    RECRUITING

    West Hills, California, 91307, United States

  • Genesis Research Services

    RECRUITING

    Broadmeadow, New South Wales, 2292, Australia

  • Horizon Clinical Research

    RECRUITING

    La Mesa, California, 91942, United States

  • JBR Clinical Research, LLC

    RECRUITING

    Salt Lake City, Utah, 84107, United States

  • Lehigh Center for Clinical Research

    RECRUITING

    Allentown, Pennsylvania, 18104, United States

  • Momentum Clinical Research Sunshine

    RECRUITING

    St Albans, Victoria, 3021, Australia

  • Momentum Clinical Research Taringa

    RECRUITING

    Taringa, Queensland, 4068, Australia

  • Momentum Clinical Research Wellers Hill

    TERMINATED

    Tarragindi, Queensland, 4121, Australia

  • Royal North Shore Hospital

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • University of the Sunshine Coast Clinical Trials, Birtinya

    RECRUITING

    Birtinya, Queensland, 4575, Australia

  • University of the Sunshine Coast Clinical Trials, Morayfield

    RECRUITING

    Morayfield, Queensland, 4506, Australia

  • University of the Sunshine Coast Clinical Trials, Noosa

    RECRUITING

    Noosaville, Queensland, 4566, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.