Knee OsteoarthritisPhase 1NCT04632966
Safety Study of PTP-001 for Treating Knee Osteoarthritis
A Phase 1 study testing Biological: PTP-001 in people with Knee Osteoarthritis, run by Bioventus LLC at 2 sites in United States.
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
- Knee Osteoarthritis
- What is being tested?
- Biological: PTP-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2021to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Written consent to participate in the study
- Male or female, aged 40 to 80 years
- Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3
- Non-responsive after at least 3 months of conservative therapy for knee OA
- Females of childbearing potential must have negative pregnancy test result prior to treatment and must commit to highly effective methods of contraception for at least 6 months after treatment
- Willingness to report oral analgesic treatment used for knee pain and to discontinue analgesic treatment for knee pain in 24 hours prior to each study visit
- Willingness to limit use of pain rescue medication to oral acetaminophen for management of painful knee OA flare
Who cannot join
- Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with condition that warrants weight loss surgery
- Presence of active infection of index knee or systemic infection requiring treatment within 3 months of Screening
- Administration of IA injection within 3 months of Screening
- Significant acute injury to index knee within 3 months of Screening
- Surgery to index knee within 6 months of Screening or planned surgery to index knee within 6 months after Screening
- Unstable index knee joint
Show all 22Show fewer
- History of radiation therapy of index knee
- Known vascular or neurological disorder affecting the index knee
- Osteonecrosis of either knee
- Clinical diagnosis of inflammatory arthritis
- Clinical diagnosis of autoimmune disease affecting the musculoskeletal system
- Use of any other investigational therapy within 3 months of Screening or planned for the duration of the study
- Current anti-coagulant use
- History of receiving a solid organ or hematologic transplant
- History of malignancy or radiotherapy within 5 years of Screening, except for basal or squamous cell carcinoma of the skin
- Use of immunosuppressive or chemotherapeutic agents within 5 years of Screening
- Known allergy to local anesthetics or allograft tissues
- Known history of hepatitis
- Known history of thrombotic or thromboembolic phenomena.
- Known history of primary or secondary immunodeficiency disorders
- Presence of concurrent medical condition that, in the investigator's judgement, could compromise participant safety or interfere with the required study assessments and study participation.
- Note: Other protocol defined inclusion/exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
James R. Urbaniak, MD, Duke Sports Science Institute
Durham, North Carolina, 27705
Coastal Carolina Research Center
North Charleston, South Carolina, 29406
About this study
Official title: A Prospective, Open-Label, Dose-Escalation Phase 1 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 open-label, dose-escalation study is expected to enroll 20 participants, 40-80 years of age and test two doses (low and high dose) of PTP-001, an allogeneic placental tissue particulate, in two unique cohorts of 10 participants each. Each participant will receive a single intra-articular (IA) injection of PTP-001. Following the completion of the first cohort in which 10 participants (Kellgren-Lawrence Grade 2 or 3 knee OA) will be treated with the low dose of PTP-001, safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB).
- Conditions
- Knee Osteoarthritis
- Being tested
- Biological: PTP-001
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: PTP-001Biological
allogeneic placental tissue particulate
| Study group | Role | What they receive |
|---|---|---|
| PTP-001 - Low Dose (100 mg) | Experimental | intra-articular injection of 100 mg PTP-001 resuspended with 4 mL of normal saline Receives: Biological: Biological: PTP-001 |
| PTP-001 - High Dose (200 mg) | Experimental | intra-articular injection of 200 mg PTP-001 resuspended with 4 mL of normal saline Receives: Biological: Biological: PTP-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels
Incidence of local and systemic treatment emergent adverse events (AEs), including clinical laboratory and immunogenicity panels, after a single intra-articular injection of PTP-001.
Measured: Baseline to Week 52
Secondary outcomes (6)
Western Ontario and McMaster University (WOMAC) Pain Responder Rate
Measured: Week 26 and Week 52
WOMAC Physical Function Responder Rate
Measured: Week 26 and Week 52
Change from baseline in pain of the index knee, by evaluating the WOMAC Pain subscale score (the possible total score ranging from 0-50 for pain)
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 11-point NRS ranging from 0 (none) to 10 (extreme), where higher score represents higher pain.
Measured: Baseline to Week 52
Change from baseline in physical function of the index knee, by evaluating the WOMAC Physical Function subscale score (the possible total score ranging from 0-170 for Physical Function)
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 pain.
Measured: Baseline to Week 52
Change from baseline in patient global assessment of OA, by assessing the participants assessment of how they are doing considering arthritis in index knee (the possible answers include "Very Good", "Good", "Acceptable", "Poor", "Very Poor"
Measured: Baseline to Week 52
Change from baseline in health-related quality of life, by assessing the items from the Short Form 36 (SF-36) survey
The SF-36 measures 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health (the possible total normalized score ranges from 0-100). Higher scores on the SF-36 indicate better health status.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start26 Feb 2021
- Primary completionSep 2022 (estimated)
- Study completionDec 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 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open-label, dose-escalation
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annunziato Amendola, MD, Principal investigator, James R. Urbaniak, MD, Duke Sports Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632966
- Sponsor's protocol ID
- KOA-20-01
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flannery CR, Seaman SA, Buddin KE, et al. Characterization and preclinical efficacy of PTP-001, a novel human tissue biologic in development for the treatment of OA. Osteoarthritis Cartilage. 2020 Apr;28(Supplement 1):S487-S489. doi: 10.1016/j.joca.2020.02.763
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 34023528
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Dose-Escalation Phase 1 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04632966
- Acronym / sponsor ID
- KOA-20-01
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bioventus LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Nov 2020 (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 open-label, dose-escalation study is expected to enroll 20 participants, 40-80 years of age and test two doses (low and high dose) of PTP-001, an allogeneic placental tissue particulate, in two unique cohorts of 10 participants each. Each participant will receive a single intra-articular (IA) injection of PTP-001. Following the completion of the first cohort in which 10 participants (Kellgren-Lawrence Grade 2 or 3 knee OA) will be treated with the low dose of PTP-001, safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, dose-escalation
| Arm | Type | Receives |
|---|---|---|
| PTP-001 - Low Dose (100 mg) | Experimental | Biological: Biological: PTP-001intra-articular injection of 100 mg PTP-001 resuspended with 4 mL of normal saline |
| PTP-001 - High Dose (200 mg) | Experimental | Biological: Biological: PTP-001intra-articular injection of 200 mg PTP-001 resuspended with 4 mL of normal saline |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written consent to participate in the study
- Male or female, aged 40 to 80 years
- Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3
- Non-responsive after at least 3 months of conservative therapy for knee OA
- Females of childbearing potential must have negative pregnancy test result prior to treatment and must commit to highly effective methods of contraception for at least 6 months after treatment
Key exclusion criteria (22 listed)
- Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with condition that warrants weight loss surgery
- Presence of active infection of index knee or systemic infection requiring treatment within 3 months of Screening
- Administration of IA injection within 3 months of Screening
- Significant acute injury to index knee within 3 months of Screening
- Surgery to index knee within 6 months of Screening or planned surgery to index knee within 6 months after Screening
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 |
|---|---|---|
| Biological: PTP-001allogeneic placental tissue particulate | Biological | PTP-001 - High Dose (200 mg), PTP-001 - Low Dose (100 mg) |
Primary outcome
Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels
Time frame: Baseline to Week 52
Incidence of local and systemic treatment emergent adverse events (AEs), including clinical laboratory and immunogenicity panels, after a single intra-articular injection of PTP-001.
6 secondary outcomes
Western Ontario and McMaster University (WOMAC) Pain Responder Rate
Time frame: Week 26 and Week 52
WOMAC Physical Function Responder Rate
Time frame: Week 26 and Week 52
Change from baseline in pain of the index knee, by evaluating the WOMAC Pain subscale score (the possible total score ranging from 0-50 for pain)
Time frame: Baseline to Week 52
Change from baseline in physical function of the index knee, by evaluating the WOMAC Physical Function subscale score (the possible total score ranging from 0-170 for Physical Function)
Time frame: Baseline to Week 52
Change from baseline in patient global assessment of OA, by assessing the participants assessment of how they are doing considering arthritis in index knee (the possible answers include "Very Good", "Good", "Acceptable", "Poor", "Very Poor"
Time frame: Baseline to Week 52
Change from baseline in health-related quality of life, by assessing the items from the Short Form 36 (SF-36) survey
Time frame: Baseline to Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- BackgroundFlannery CR, Seaman SA, Buddin KE, et al. Characterization and preclinical efficacy of PTP-001, a novel human tissue biologic in development for the treatment of OA. Osteoarthritis Cartilage. 2020 Apr;28(Supplement 1):S487-S489. doi: 10.1016/j.joca.2020.02.763
- 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.
- 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.
Annunziato Amendola, MD principal investigator
James R. Urbaniak, MD, Duke Sports Science Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biological: PTP-001 in people with Knee Osteoarthritis, run by Bioventus LLC at 2 sites in United States.
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 7 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels (time frame: Baseline to Week 52). 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 NCT04632966, 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 22 Dec 2021.