A Phase 3 Prospective Multicenter Double-Blind Randomized Placebo Controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients with Osteoarthritis of the Knee

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosis of osteoarthritis (OA) of the knee by a combination of clinical and radiographic findings
    2. OA of the knee with Kellgren and Lawrence radiographic classification (Grades 2-4 inclusive,)
    3. Those who have failed to adequately respond for at least 6 months to at least two osteoarthritis therapies
    4. Overall pain score of 11 or more over the previous 7 days using the WOMAC Pain scale
    5. Body mass index < 40 kg/m2
    6. Females must be postmenopausal, surgically sterilized, sexually abstinent, or willing and able to use 2 methods of contraception from Day 1 through 12 months after treatment
    7. Males who are not surgically sterile (vasectomy) for at least 6 months prior to screening must confirm a willingness to use adequate methods of contraception from Day 1 through 12 months after treatment
    8. Willing to agree not to use illicit drugs during the study, and to have illicit drug testing at screening and at later time points, if illicit drug use is suspected during the study
    9. Able to comply with study requirements and complete the full sequence of protocol-related procedures and evaluations
    10. Able to understand and provide written informed consent

You may not be eligible for this study if the following are true:

    1. Use of pain medication
    2. Regular use of anticoagulants
    3. Corticosteroid injection into the index knee within 3 months prior to screening
    4. Viscosupplement (e.g., hyaluronic acid [HA]) injection, platelet-rich plasma injection, bone marrow aspirate or bone marrow aspiration concentrate, placental-derived tissue/cells, adipose tissue, or any other autologous or allogeneic product into the index knee
    5. Patients with known hypersensitivity reactions to ASA or any of its constituents
    6. Knee surgery on the index knee within 12 months prior to screening
    7. Knee surgery on the contralateral knee within 6 months prior
    8. Acute index knee trauma within 3 months prior
    9. Knee effusion requiring aspiration of the index or contralateral knee
    10. Contralateral knee pain > 4 on the WOMAC pain scale on most days during the past week
    11. Current therapy with any immunosuppressive therapy
    12. Clinically significant findings on screening laboratory tests or physical examination that are not specific to OA of the knee
    13. Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history that would jeopardize patient safety, limit participation, or compromise interpretation of data
    14. Active alcohol or substance use disorder
    15. Females who are pregnant or lactating
    16. Participation in another clinical trial within the 30 days

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