Could a placenta injection ease your knee pain?
NCT ID NCT07219771
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 Hide 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.
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
16 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
-
Central Research Associates, LLC dba Flourish Research
RECRUITINGBirmingham, Alabama, 35205, United States
-
Chicago Clinical Research Institute, Inc.
RECRUITINGChicago, Illinois, 60607, United States
-
Coastal Carolina Research Center, LLD
RECRUITINGNorth Charleston, South Carolina, 29405, United States
Contact Email: •••••@•••••
-
Conquest Research, LLC
RECRUITINGWinter Park, Florida, 32789, United States
-
Emeritus Research Sydney
RECRUITINGBotany, New South Wales, 2019, Australia
-
Focus Clinical Research
RECRUITINGWest Hills, California, 91307, United States
-
Genesis Research Services
RECRUITINGBroadmeadow, New South Wales, 2292, Australia
-
Horizon Clinical Research
RECRUITINGLa Mesa, California, 91942, United States
-
JBR Clinical Research, LLC
RECRUITINGSalt Lake City, Utah, 84107, United States
-
Lehigh Center for Clinical Research
RECRUITINGAllentown, Pennsylvania, 18104, United States
-
Momentum Clinical Research Sunshine
RECRUITINGSt Albans, Victoria, 3021, Australia
-
Momentum Clinical Research Taringa
RECRUITINGTaringa, Queensland, 4068, Australia
-
Momentum Clinical Research Wellers Hill
TERMINATEDTarragindi, Queensland, 4121, Australia
-
Royal North Shore Hospital
RECRUITINGSt Leonards, New South Wales, 2065, Australia
-
University of the Sunshine Coast Clinical Trials, Birtinya
RECRUITINGBirtinya, Queensland, 4575, Australia
-
University of the Sunshine Coast Clinical Trials, Morayfield
RECRUITINGMorayfield, Queensland, 4506, Australia
-
University of the Sunshine Coast Clinical Trials, Noosa
RECRUITINGNoosaville, Queensland, 4566, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can robotic surgery personalize knee replacement?
- Custom knee guides put to the test in obese patients
- Can a shot of your own blood ease arthritic knees?
- 5,000 knee arthritis patients tracked to crack the treatment code
- Can a hydrogel injection ease knee arthritis pain?
- Weekly shot aims to melt away pounds in obesity fight