Knee OsteoarthritisPhase 3MOTION-PNCT07219771
A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients (MOTION-P)
A Phase 3 study testing PTP-01 in people with Knee Osteoarthritis, run by Doron Therapeutics Inc. at 18 sites in 2 countries.
Trial summary
This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PTP-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 14 Oct 2025to 30 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 40 to 80 years.
- 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.
- Primary source of pain throughout the body is due to OA in the target knee.
- 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.
- Onset of symptomatic OA of the target knee was at least 6 months prior to Screening.
- Insufficient, failed response, or intolerance to analgesics and / or non-steroidal anti-inflammatory drugs (NSAIDs), as reported by the participant.
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- If female, must meet all of the following:
- Not breast feeding,
- Not planning to become pregnant during the study,
- Must abstain from ova / egg donation during the study,
- 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.
- Willing to use acetaminophen as the only oral rescue (as needed) analgesic medication for target knee pain during the study.
- Willing to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study.
- Willing to comply with study visit schedule and post-injection restrictions.
- Written informed consent is obtained from the participant.
Who cannot join
- Participant is non-ambulatory (unable to walk > 50 feet / 15 meters without assistance).
- Clinically severe obesity as defined by the National Institutes of Health (body mass index ≥ 40 kg/m2) at Screening and / or Baseline.
- 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.
- At Baseline, difference between the first Baseline and second Baseline WOMAC pain scores is > 3 for the target knee.
- Contralateral (non-target) knee pain is experienced for ≥ 14 days in the month.
- Use of any analgesia during the washout period (5 half-lives) at Screening or Baseline.
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- 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.
- Currently requires use of a lower extremity prosthesis and / or a structural knee brace (ie, a knee brace that contains hardware).
- 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.
- 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.
- Presence of active infection in the target knee or systemic infection requiring treatment within the 3 months prior to Screening.
- Clinical diagnosis of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology.
- Participant is receiving, has received, or plans to receive any of the following therapies:
- 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.
- 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.
- Current chronic systemic use of corticosteroids in doses exceeding the equivalent of 10 mg prednisolone daily.
- Treatment with any investigational therapy (drug, device, or biologic) within 3 months prior to Screening or is planned for the duration of the study.
- Treatment with immunosuppressive medication (not including mild transient immunosuppressants such as corticosteroids) or chemotherapy within the past 5 years.
- Chronic use of narcotics or alcohol abuse within the past 6 months prior to Screening.
- 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.
- Participant previously underwent arthroplasty (ie, full or partial knee replacement) of the target knee.
- 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).
- Diagnosis of lower extremity gout or pseudo-gout in the past 6 months prior to Screening.
- History of, or current manifestation of, osteonecrosis of either knee.
- Significant acute (within the past 3 months) injury to the target knee.
- History of receiving a solid organ or hematologic transplant.
- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin.
- History of prior radiation therapy of the target knee.
- History of autoimmune disease affecting the musculoskeletal system.
- Known (documented) history of acquired immune deficiency syndrome or human immunodeficiency virus (HIV).
- 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.
- 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.
- 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.
- Participant is involved in litigation (eg, worker's compensation) for a medical condition or injury at any anatomical site.
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
United States9 sites, 8 recruiting
- Withdrawn
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
- Recruiting
Central Research Associates, LLC dba Flourish Research
Birmingham, Alabama, 35205
Baleigh Baker, 659-209-5575, bbaker@flourishresearch.com
Kaylee Harris, 659-209-5575, kaylee.harris@flourishresearch.com
- Recruiting
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, 60607
Saad Syed, MD, 312-791-3241 ext. 313, ssyed@ccrii.us
Dennis Levinson, MD
- Recruiting
Horizon Clinical Research
La Mesa, California, 91942
Tiffany King, 619-456-6012 ext. 1, tiffany@horizontrials.com
Scott Hacker, MD
- Recruiting
Coastal Carolina Research Center, LLD
North Charleston, South Carolina, 29405
Mary Love, 312-878-9477, recruitment@alcanzaclinical.com
Shailesh Patel, MD
- Recruiting
JBR Clinical Research, LLC
Salt Lake City, Utah, 84107
Jenny Hunt, 801-261-2000, j.hunt@cenexel.com
Mike McCarthy, 801-261-2000, m.mcarthy@cenexel.com
- Recruiting
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Nebojsa Skrepnik, 520-404-0276, nskrepnik@tucsonortho.com
Nebojsa Skrepnik
- Recruiting
Focus Clinical Research
West Hills, California, 91307
Carlos Uribe, 818-253-8966, curibe@allianceclinicalnetwork.com
Guillermo Acosta, 818-253-8966, gacosta@allianceclinicalnetwork.com
- Recruiting
Conquest Research, LLC
Winter Park, Florida, 32789
Laura Kelly, 407-916-0060, Laura.Kelly@conquestresearch.com
Aanand Patel, MD
Australia9 sites, 3 recruiting
- Active, not recruiting
University of the Sunshine Coast Clinical Trials, Birtinya
Birtinya, Queensland, 4575
- Terminated
Emeritus Research Sydney
Botany, New South Wales, 2019
- Recruiting
Genesis Research Services
Broadmeadow, New South Wales, 2292
Emily Allard, 61 2 4985 1860, emily@genesisresearchservices.com
Deon Smith
- Recruiting
University of the Sunshine Coast Clinical Trials, Maroochydore
Maroochydore, Queensland, 4566
Stephanie Wallace, 61 7 5456 3797, swallac1@usc.edu.au
Stephanie Wallace
- Active, not recruiting
University of the Sunshine Coast Clinical Trials, Morayfield
Morayfield, Queensland, 4506
- Recruiting
Momentum Clinical Research Sunshine
St Albans, Victoria, 3021
Site Manager, 61 3 9125 0799, sunshine@momcr.com
Roy Rasalam
- Active, not recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2065
- Active, not recruiting
Momentum Clinical Research Taringa
Taringa, Queensland, 4068
- Terminated
Momentum Clinical Research Wellers Hill
Tarragindi, Queensland, 4121
About this study
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
This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis.
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-week period in participants with radiographic and symptomatic knee OA.
Read the detailed description
The participants will be randomized in a 1:1 ratio to receive one of either PTP-001 or placebo injection. Each participant will be administered a single dose of investigational product (IP) (active or placebo) on Day 1.
The trial will consist of a Screening period (up to 28 days prior to treatment), a treatment phase (1 day) and a follow-up phase (12 months following treatment). A total of at least 260 participants are planned to be randomized (130 participants/group).
- Conditions
- Knee Osteoarthritis
- Being tested
- PTP-01, Placebo control / saline vehicle
- Keywords
- Osteoarthritis, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTP-01Biological
Also called MOTYS™, allogeneic human placental tissue particulate
Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.
Placebo control / saline vehicleOther
Also called Normal saline, Physiological saline
The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.
| Study group | Role | What they receive |
|---|---|---|
| PTP-001 200 mg | Experimental | A single intra-articular injection in the target knee of PTP-001 200 mg Receives: Biological: PTP-01 |
| Placebo / saline vehicle | Placebo comparator | A single intra-articular injection in the target knee of 4 mL of placebo control (0.9% sodium chloride injection, USP) Receives: Other: Placebo control / saline vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants meeting strict responder criteria for improvement in knee function.
To qualify as a "strict responder for improvement in knee function", an improvement of ≥ 50% in WOMAC Function subscale score is required, with an absolute change ≥ 20 points in the score.
Measured: 6 months
Proportion of participants meeting strict responder criteria for improvement in knee pain.
To qualify as a "strict responder for improvement in knee pain", an improvement of ≥ 50% in WOMAC Pain subscale score is required, with an absolute change ≥ 20 points in the score.
Measured: 6 months
Secondary outcomes (5)
Proportion of participants meeting strict responder criteria for improvement in knee function.
Measured: 9 months and 12 months
Proportion of participants meeting strict responder criteria for improvement in knee pain.
Measured: 9 months and 12 months
Change from pretreatment Baseline in participant self-reported assessment of OA by PGA-OA score.
Measured: 6 months, 9 months, and 12 months
Change from pretreatment Baseline in participant self-reported function of the treated knee as assessed by WOMAC Function subscale score.
Measured: 6 months, 9 months, and 12 months
Change from pretreatment Baseline in participant self-reported pain at the treated knee as assessed by WOMAC Pain subscale score.
Measured: 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start14 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doron Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Professor David Hunter, Principal investigator, Chair of Rheumatology at University of Sydney and Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219771
- Sponsor's protocol ID
- KOA-25-03
- Acronym
- MOTION-P
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flannery CR, Buddin KE, Begum L, Nasert MA, Catalfamo B, Semler EJ, Fortier LA. Composition and Bioactivity of a Placental Tissue Particulate (PTP-001) Indicate Greater Potential than Platelet-Rich Plasma for the Treatment of Osteoarthritis. Cartilage. 2023 Dec;14(4):467-472. doi: 10.1177/19476035231159748. Epub 2023 Mar 13.
PubMed 36912174Flannery CR, Seaman SA, Buddin KE, Nasert MA, Semler EJ, Kelley KL, Long M, Favret J, Pavesio A, Loeser RF. 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. Osteoarthritis Cartilage. 2021 Aug;29(8):1203-1212. doi: 10.1016/j.joca.2021.03.022. Epub 2021 May 20.
PubMed 34023528
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07219771
- Acronym / sponsor ID
- MOTION-P / KOA-25-03
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Doron Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis.
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-week period in participants with radiographic and symptomatic knee OA.
Detailed description
The participants will be randomized in a 1:1 ratio to receive one of either PTP-001 or placebo injection. Each participant will be administered a single dose of investigational product (IP) (active or placebo) on Day 1.
The trial will consist of a Screening period (up to 28 days prior to treatment), a treatment phase (1 day) and a follow-up phase (12 months following treatment). A total of at least 260 participants are planned to be randomized (130 participants/group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTP-001 200 mg | Experimental | Biological: PTP-01A single intra-articular injection in the target knee of PTP-001 200 mg |
| Placebo / saline vehicle | Placebo comparator | Other: Placebo control / saline vehicleA single intra-articular injection in the target knee of 4 mL of placebo control (0.9% sodium chloride injection, USP) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Males and females aged 40 to 80 years.
- 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.
- Primary source of pain throughout the body is due to OA in the target knee.
- 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.
- Onset of symptomatic OA of the target knee was at least 6 months prior to Screening.
Key exclusion criteria (35 listed)
- Participant is non-ambulatory (unable to walk > 50 feet / 15 meters without assistance).
- Clinically severe obesity as defined by the National Institutes of Health (body mass index ≥ 40 kg/m2) at Screening and / or Baseline.
- 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.
- At Baseline, difference between the first Baseline and second Baseline WOMAC pain scores is > 3 for the target knee.
- Contralateral (non-target) knee pain is experienced for ≥ 14 days in the month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTP-01Also: MOTYS™, allogeneic human placental tissue particulateAllogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline. | Biological | PTP-001 200 mg |
| Placebo control / saline vehicleAlso: Normal saline, Physiological salineThe placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee. | Other | Placebo / saline vehicle |
Primary outcome
Proportion of participants meeting strict responder criteria for improvement in knee function.
Time frame: 6 months
To qualify as a "strict responder for improvement in knee function", an improvement of ≥ 50% in WOMAC Function subscale score is required, with an absolute change ≥ 20 points in the score.
Proportion of participants meeting strict responder criteria for improvement in knee pain.
Time frame: 6 months
To qualify as a "strict responder for improvement in knee pain", an improvement of ≥ 50% in WOMAC Pain subscale score is required, with an absolute change ≥ 20 points in the score.
5 secondary outcomes
Proportion of participants meeting strict responder criteria for improvement in knee function.
Time frame: 9 months and 12 months
Proportion of participants meeting strict responder criteria for improvement in knee pain.
Time frame: 9 months and 12 months
Change from pretreatment Baseline in participant self-reported assessment of OA by PGA-OA score.
Time frame: 6 months, 9 months, and 12 months
Change from pretreatment Baseline in participant self-reported function of the treated knee as assessed by WOMAC Function subscale score.
Time frame: 6 months, 9 months, and 12 months
Change from pretreatment Baseline in participant self-reported pain at the treated knee as assessed by WOMAC Pain subscale score.
Time frame: 6 months, 9 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 36912174Flannery CR, Buddin KE, Begum L, Nasert MA, Catalfamo B, Semler EJ, Fortier LA. Composition and Bioactivity of a Placental Tissue Particulate (PTP-001) Indicate Greater Potential than Platelet-Rich Plasma for the Treatment of Osteoarthritis. Cartilage. 2023 Dec;14(4):467-472. doi: 10.1177/19476035231159748. Epub 2023 Mar 13.
- Results publication: PubMed 34023528Flannery CR, Seaman SA, Buddin KE, Nasert MA, Semler EJ, Kelley KL, Long M, Favret J, Pavesio A, Loeser RF. 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. Osteoarthritis Cartilage. 2021 Aug;29(8):1203-1212. doi: 10.1016/j.joca.2021.03.022. Epub 2021 May 20.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Professor David Hunter principal investigator
Chair of Rheumatology at University of Sydney and Royal North Shore Hospital
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PTP-01 in people with Knee Osteoarthritis, run by Doron Therapeutics Inc. at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Kathryn Kottke (919-355-4630, mk.kottke@dorontherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants meeting strict responder criteria for improvement in knee function. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07219771, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.