Osteoarthritis, KneePhase 2NCT05100225
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
A Phase 2 study testing PTP-001 in people with Osteoarthritis, Knee, run by Bioventus LLC at 14 sites in 3 countries.
Trial summary
Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PTP-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 30 Sep 2021to 30 Nov 2022
- Phase
- Phase 2
- 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
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female, aged 40 to 80 years
- Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3 (mild or moderate) as assessed by the central reading facility
- Target knee pain ≥ 20 and ≤ 40 out of 50 the WOMAC®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 or failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs, 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
- 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 (See Appendix A) for at least 12 weeks after the injection
- Willingness to remain on the same oral "rescue" (as needed) analgesic as the only pharmacologic treatment for knee pain during the study
- Willingness to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study
- Written informed consent is obtained from the participant
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Participant is non-ambulatory (unable to walk >50 feet without assistance)
- Clinically severe obesity as defined by the National Institutes of Health (body mass target ≥40 kg/m2)
- Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC® NRS3.1 pain questionnaire) at screening and/or baseline
- Clinically significant effusion of the target knee at either the screening or baseline visits determined by physical examination (e.g., 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.
- Severe (excessive) malalignment of the tibial-femoral axis, assessed radiographically
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- Presence of active infection of the target knee or systemic infection requiring treatment within the 3 months prior to screening
- Clinical diagnosis of inflammatory arthritis (e.g., 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 (e.g., 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 intra-articular corticosteroid 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 10 mg prednisolone-equivalents 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 or chemotherapy within the past 5 years
- Chronic use of narcotics or alcohol abuse within the past 6 months prior to screening
- Surgery to the target knee (including arthroscopy) within 6 months prior to receiving the intra-articular injection or planned surgery to the target knee within 6 months after the injection
- Participant previously underwent arthroplasty 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)
- Symptomatic OA of the non-target knee that is not responsive to paracetamol (acetaminophen) or oral nonsteroidal anti-inflammatory drugs (NSAIDs).
- Diagnosis of lower extremity gout or pseudo-gout in the past 6 months
- 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
- Any condition causing pain in or around the target knee (e.g., radiating pain, 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 fibromyalgia, neuropathic pain, low back pain, etc.
- Presence of contraindications for use of 3 g/day of orally administered paracetamol/acetaminophen due to known hypersensitivity or hepatic impairment.
- Known presence of any concurrent medical condition (e.g., hematologic renal, hepatic, cardiac, or coagulation abnormalities) that in the investigator's judgment would interfere with the required study assessments and study participation
- Participant is involved in litigation (e.g., worker's compensation) for a medical condition or injury at any anatomical site
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Canada6 sites
Hamilton Medical Research Group
Hamilton, Ontario, L8M 1K7
McMaster University Department of Surgery St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Diex Recherche Quebec Inc.
Québec, Quebec, G1N4V3
Centrede Recherche Saint-Louis
Québec, Quebec, G1W 4R4
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
Australia5 sites
Emeritus Research Sydney
Botany, New South Wales, 2019
Genesis Research Services
Broadmeadow, New South Wales, 2292
Emeritus Research Melbourne
Camberwell, Victoria, 3124
Royal North Shore Hospital
Saint Leonards, New South Wales
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Denmark3 sites
Sanos Clinic Nordjylland
Gandrup, 9362
Sanos Clinic
Herlev, 2730
Sanos Clinic Syddanmark
Vejle, 7100
About this study
Official title: A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).
Read the detailed description
This is a multiple arm, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, phase 2 study of intra-articular administration of an allogeneic human placental tissue particulate (PTP-001) for the treatment of knee osteoarthritis. The study is planned to be conducted outside the United States. A total of approximately 210 participants are planned to be randomized to receive 1 of 2 doses of PTP-001 (100 mg or 200 mg) or saline vehicle control (placebo) injection. The purpose of the trial is to evaluate the efficacy, safety and tolerability of a single low dose and high dose of PTP-001 compared to placebo over a 26-week period.
- Conditions
- Osteoarthritis, Knee
- Being tested
- PTP-001, Placebo control
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTP-001Biological
Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.
Placebo controlOther
Also called 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-001 |
| PTP-001 100 mg | Experimental | A single intra-articular injection in the target knee of PTP-001 100 mg. Receives: Biological: PTP-001 |
| Placebo/saline | Placebo comparator | A single intra-articular injection in the target knee of 4mL of placebo control - physiological saline (0.9% sodium chloride injection, USP). Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Change from pretreatment baseline in the WOMAC pain subscale
To evaluate the change from pretreatment baseline in the WOMAC pain sub-score in the target knee on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized on scales of 0-100.
Measured: At 6 months
Safety - Incidence of local and systemic AEs
To assess the long-term (6 months) incidence of local and systemic AEs, and consists of physical examination, laboratory values, AEs, AESI, and immunogenicity testing.
Measured: Over 6 months
Secondary outcomes (6)
Change from pretreatment baseline in pain intensity assessed by participant self report (WOMAC Pain subscale).
WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) is measured on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized to a scale of 0-100, where higher score represents higher pain.
Measured: At 2 weeks, 3 months, 4 months, 5 months.
Change from pretreatment baseline in function assessed by participant self-report (WOMAC Function subscale).
WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) is measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where higher score represents higher difficulties in physical function.
Measured: At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Change from pretreatment baseline in the weekly average of daily pain assessed by patient self report (NRS).
The question is an average daily (24-h) pain intensity score on a 0 to 10 NRS scale with 0 indicating 'no pain' and 10 indicating 'pain as bad as you can imagine'.
Measured: At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Change from pretreatment baseline in patient global assessment of OA (PGA-OA) assessed by participant self report.
Considering all the ways knee osteoarthritis affects the participants, the question is an average daily (24-h) self-reported global assessment on an 11-box numerical rating scale, with 0 indicating "very good" and 10 indicating "very poor".
Measured: At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Change from pretreatment baseline in participant self-reported quality of life measured by SF-36 overall score, PCS, and MCS.
The SF-36 measures 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health, and has 2 summary scores (physical and mental). The physical health measure includes 4 scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items).
The assessment is performed on a scale of 0 (maximum disability)-100 (no disability) with higher scores indicating better health status.
Measured: At 3 months and 6 months.
Response to PTP-001 on the OMERACT-OARSI responder criteria.
The OMERACT-OARSI responder criteria involve changes that are deemed to be clinically relevant in the three domains: pain, function, and Patient Global Assessment. For each of these domains, ranges are defined for absolute and percent changes from baseline that correspond to "high improvement" and "moderate improvement". OMERACT-OARSI response is defined as either i) improvement in pain or physical function ≥50% and an absolute change ≥20 mm on a 100-mm visual analog scale; or (2) improvement of ≥20% and with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment (PGA).
Measured: At 2 weeks, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start30 Sep 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Nov 2022 (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 Osteoarthritis, KneeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NBCD A/S
- Responsible party
- Sponsor
- Investigators
- Moin Khan, MD, Principal investigator, McMaster University Department of Surgery St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100225
- Sponsor's protocol ID
- KOA-21-02
- Status last verified
- Jul 2022
- First submitted
- 19 Oct 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flannery 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 34023528James JJ, Pahal S, Jayaraman A, Nayak A D, Koteshwar Narasimhachar S, Sundarrajan S, Basappa Veerabhadraiah B, Srinivasan B, Vemula PK, Nguyen TD, Kadamboor Veethil S. Polymeric Microneedles for Transdermal Delivery of Human Placental Tissue for the Treatment of Osteoarthritis. Macromol Biosci. 2025 Mar;25(3):e2400485. doi: 10.1002/mabi.202400485. Epub 2024 Dec 20.
PubMed 39704612
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05100225
- Acronym / sponsor ID
- KOA-21-02
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Bioventus LLCIndustry (pharma, biotech, devices)
- Collaborators
- NBCD A/S
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 29 Oct 2021 (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.
Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).
Detailed description
This is a multiple arm, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, phase 2 study of intra-articular administration of an allogeneic human placental tissue particulate (PTP-001) for the treatment of knee osteoarthritis. The study is planned to be conducted outside the United States. A total of approximately 210 participants are planned to be randomized to receive 1 of 2 doses of PTP-001 (100 mg or 200 mg) or saline vehicle control (placebo) injection. The purpose of the trial is to evaluate the efficacy, safety and tolerability of a single low dose and high dose of PTP-001 compared to placebo over a 26-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study
| Arm | Type | Receives |
|---|---|---|
| PTP-001 200 mg | Experimental | Biological: PTP-001A single intra-articular injection in the target knee of PTP-001 200 mg. |
| PTP-001 100 mg | Experimental | Biological: PTP-001A single intra-articular injection in the target knee of PTP-001 100 mg. |
| Placebo/saline | Placebo comparator | Other: Placebo controlA single intra-articular injection in the target knee of 4mL of placebo control - physiological saline (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 (13 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
Key exclusion criteria (32 listed)
- Participants are excluded from the study if any of the following criteria apply:
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-001Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline. | Biological | PTP-001 100 mg, PTP-001 200 mg |
| Placebo controlAlso: 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 |
Primary outcome
Efficacy - Change from pretreatment baseline in the WOMAC pain subscale
Time frame: At 6 months
To evaluate the change from pretreatment baseline in the WOMAC pain sub-score in the target knee on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized on scales of 0-100.
Safety - Incidence of local and systemic AEs
Time frame: Over 6 months
To assess the long-term (6 months) incidence of local and systemic AEs, and consists of physical examination, laboratory values, AEs, AESI, and immunogenicity testing.
6 secondary outcomes
Change from pretreatment baseline in pain intensity assessed by participant self report (WOMAC Pain subscale).
Time frame: At 2 weeks, 3 months, 4 months, 5 months.
Change from pretreatment baseline in function assessed by participant self-report (WOMAC Function subscale).
Time frame: At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Change from pretreatment baseline in the weekly average of daily pain assessed by patient self report (NRS).
Time frame: At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Change from pretreatment baseline in patient global assessment of OA (PGA-OA) assessed by participant self report.
Time frame: At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Change from pretreatment baseline in participant self-reported quality of life measured by SF-36 overall score, PCS, and MCS.
Time frame: At 3 months and 6 months.
Response to PTP-001 on the OMERACT-OARSI responder criteria.
Time frame: At 2 weeks, 3 months, and 6 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 19 Jul 2022.
- Background: 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.
- Derived from this study: PubMed 39704612James JJ, Pahal S, Jayaraman A, Nayak A D, Koteshwar Narasimhachar S, Sundarrajan S, Basappa Veerabhadraiah B, Srinivasan B, Vemula PK, Nguyen TD, Kadamboor Veethil S. Polymeric Microneedles for Transdermal Delivery of Human Placental Tissue for the Treatment of Osteoarthritis. Macromol Biosci. 2025 Mar;25(3):e2400485. doi: 10.1002/mabi.202400485. Epub 2024 Dec 20.
- 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. This study is not recruiting at the moment.
Moin Khan, MD principal investigator
McMaster University Department of Surgery St. Joseph's Healthcare Hamilton
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTP-001 in people with Osteoarthritis, Knee, run by Bioventus LLC at 14 sites in 3 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 13 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada, Australia, Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - Change from pretreatment baseline in the WOMAC pain subscale (time frame: At 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 NCT05100225, 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 19 Jul 2022.