CLINICAL TRIAL

Biological: PTP-001 for Osteoarthritis, Knee

Waitlist Available · 18+ · All Sexes · North Charleston, SC

This study is evaluating whether a single injection of placental tissue may help treat knee osteoarthritis.

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About the trial for Osteoarthritis, Knee

Eligible Conditions
Osteoarthritis, Knee · Osteoarthritis · Osteoarthritis of the Knee

Treatment Groups

This trial involves 2 different treatments. Biological: PTP-001 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Biological: PTP-001
BIOLOGICAL
Experimental Group 2
Biological: PTP-001
BIOLOGICAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or female, aged 40 to 80 years
Written consent to participate in the study
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 26 and Week 52
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 26 and Week 52.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Biological: PTP-001 will improve 1 primary outcome, 6 secondary outcomes, and 2 other outcomes in patients with Osteoarthritis, Knee. Measurement will happen over the course of Baseline to Week 52.

Change from baseline in joint space width of the index knee, assessed radiographically (OARSI radiographic scoring)
BASELINE TO WEEK 52
Change from baseline in biochemical markers (CTX-II & PRO-C2)
BASELINE TO WEEK 52
Urinary CTX-II samples Serum PRO-C2 samples
Change from baseline in health-related quality of life, by assessing the items from the Short Form 36 (SF-36) survey
BASELINE TO WEEK 52
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.
Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels
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.
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)
BASELINE TO WEEK 52
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.
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"
BASELINE TO WEEK 52
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the latest research for osteoarthritis, knee?

The main findings of the major studies for knee OA are summarized in the table. The most important conclusion may be that the evidence base needs to be strengthened and that the major hypotheses for knee OA should continue to be explored with caution. It is clear that knee OA is not a single condition. While there exists some degree of consensus about the most likely causes of knee OA, it appears that the mechanisms that are responsible for initiating and exacerbating this process are uncertain.

Anonymous Patient Answer

Has biological: ptp-001 proven to be more effective than a placebo?

Results from a recent paper demonstrates the potential of the novel drug, PTP-001, to have meaningful clinical benefits for knee OA. Due to these results, a subsequent phase 2 trial is planned.

Anonymous Patient Answer

What are common treatments for osteoarthritis, knee?

Common treatments for knee OA include medications, physical therapy, injections and joint replacement. It is important to understand the differences in risk, efficacy, and side effects between different OA treatments.

Anonymous Patient Answer

What causes osteoarthritis, knee?

Identifying a cause with a clear molecular link may help improve our understanding of arthritic disease. Moreover, this knowledge may help to design targeted therapeutic interventions using new agents. Further investigation may lead to the introduction of new treatments for knee OA.

Anonymous Patient Answer

What is osteoarthritis, knee?

OA develops in approximately 70% of adults over age 65. One of the most common sites is the patella (kneecap). Other common sites include the tibiofemoral joint (shin), carpometacarpal joints (carpus or metacarpus, wrist and fingers), and spine (neck, shoulders, ribs). There is also joint space reduction in the shoulder, hip, knee, and spine. The exact nature of disease in any individual is unknown. It is believed to be multifactorial with both genetic predisposition and non-shared environmental exposures, including physical, psychological, and behavioral factors.

Anonymous Patient Answer

How many people get osteoarthritis, knee a year in the United States?

Osteoarthritis of the knee is one of the most important health problems in the United States. Approximately 4.1 million men have osteoarthritis of the knee.

Anonymous Patient Answer

Can osteoarthritis, knee be cured?

Osteoarthritis, Knee can be cured by using conservative approach. Even for patients with advanced radiologic evidence of OA, satisfactory clinical and functional success rates can be obtained after a single surgical procedure. In particular, the results of this study indicate that a single procedure of arthrodesis or TKA yields satisfactory long postoperative results in selected patients.

Anonymous Patient Answer

What are the signs of osteoarthritis, knee?

Osteoarthritis, when there is severe stiffness and inability to move the joint, is the first symptom of knee OA to be present in half of cases. The knee joint is also more likely to be painful compared with other joints. Patients usually complain to physicians, in addition to other symptoms, about the pain and stiffness.

Anonymous Patient Answer

Is biological: ptp-001 typically used in combination with any other treatments?

Patients with [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) have demonstrated that this therapy can improve arthritis symptoms over placebo and is not significantly more effective than sham in all parameters of the study. Therefore, the results of this study do not provide evidence supporting the use of ptp-001 as a stand-alone biological treatment of osteoarthritis or for the treatment of osteoarthritis when administered in combination with other treatments.

Anonymous Patient Answer

What are the latest developments in biological: ptp-001 for therapeutic use?

The development of biological, or biomimetic technologies may offer new therapeutic strategies that can be developed to modulate the immune-related pathways in the joints of OA patients, and these may offer a paradigm shift towards understanding the cause of the disease. This could in part offer clinicians, patients, and/or policy makers the opportunity to improve outcomes in patients with this disabling disease.

Anonymous Patient Answer

How serious can osteoarthritis, knee be?

Recent findings demonstrates that persons with [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) may be as healthy as their age- and sex-matched counterparts without osteoarthritis, with only 7% more pain on a constant pain rating scale. These persons have an extra 16-18 years of life without needing surgery to treat or relieve pain. The age and sex-matched cohorts without osteoarthritis had to be aged in their 30s and 40s, respectively, to have an extra 12-18 years of life. Recent findings indicate that osteoarthritis of the knee affects the majority of Americans with arthritis.

Anonymous Patient Answer

Have there been other clinical trials involving biological: ptp-001?

Since there has been no new report on ptp-001 to the medical specialty area of cartilage diseases, clinical trials may be needed to validate its efficacy and safety.

Anonymous Patient Answer
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