Clinical trial: Study of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis (NCT04835389)

Eligibility criteria:
Inclusion Criteria:

          -  Subject has both clinical and radiographic findings consistent with osteoarthritis of
             the knee:

               1. Subject has clinical findings including (but not limited to) tenderness to
                  palpation, swelling/effusion, stiffness, chronic limited range of motion.

               2. Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 2 to 3 using
                  the Kellgren-Lawrence grading scale.

          -  Failed conservative care over the past 3 months of at least 2 conservative treatments
             including oral pain medication [analgesics, steroids and/or non-steroidal
             anti-inflammatory drugs (NSAIDs)] and structured physical therapy or exercise program
             prescribed by physical therapist, chiropractor provider or physician specifically for
             the treatment of knee osteoarthritis.

          -  Subject has a BMI less than 40 kg/m2

          -  Subject is willing and able to provide informed consent and participate in all
             procedures and follow-up evaluations necessary to complete the study.

          -  Subject must have a VAS pain score of 4 or greater on a 100-mm scale.

          -  All subjects of reproductive age or capacity must use adequate contraception
             (abstinence, surgically sterilized, postmenopausal, or consistently use an effective
             contraception method) during the study.

          -  Subject agrees not to take additional knee symptom-modifying drugs (e.g., glucosamine,
             collagen, hyaluronic acid) during the study without reporting the use to the study
             team.

        Exclusion Criteria:

          -  Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 4 on the
             Kellgren-Lawrence grading scale.

          -  Subject has active infection at the injection site.

          -  Subject has symptomatic OA of the contralateral knee or of either hip (VAS≥40) that is
             not responsive to acetaminophen (Tylenol®) and/or Non-Steroidal Anti-Inflammatory
             Drugs (NSAIDs, e.g. Ibuprofen) and requires other therapy.

          -  Subject has rheumatoid arthritis, psoriatic arthritis, or has been diagnosed with any
             other disorders that is the primary source of their knee pain, including but not
             limited to:

        osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer.

          -  Subject has documented history of gout or pseudo-gout.

          -  Subject has a known allergy to local anesthetics.

          -  Subject has autoimmune disease or a known history of having Acquired Immunodeficiency
             Syndromes (AIDS) or Human Immunodeficiency Virus (HIV).

          -  Subject has diagnosis of hematologic, renal, hepatic, or coagulation abnormalities
             based on medical history and laboratory results.

          -  Subject has received any of the following to the target knee:

               1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to
                  screening;

               2. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to
                  screening;

               3. Has had or is planning to have major surgery in the target knee within 26 weeks
                  of treatment; or

               4. History of unicondylar or total knee arthroplasty.

          -  Subject is currently participating in another clinical trial or has used an
             investigational drug, device or biologic within 12 weeks prior to treatment.

          -  Subject has a history of immunosuppressive use or chemotherapy in the last 12 months.

          -  Subject has had prior radiation to the index knee.

          -  Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin).

          -  Subject is breast feeding or pregnant or plans to become pregnant within 12 weeks of
             treatment.

          -  Subject has any significant medical condition that, in the opinion of the
             Investigator, would increase the chances of an adverse event and/or would interfere
             with protocol evaluation and participation.

          -  Subject is a worker's compensation patient.

          -  Subject has taken pain medication <48 hours prior to the injection or has received
             pain medicine other than acetaminophen and/or NSAIDs for conditions unrelated to OA of
             the index knee.

          -  Subject has a history of alcohol or substance abuse.

          -  Physical or IA injection exclusion criteria include:

               1. Frank mechanical symptoms such as locking, intermittent block to range of motion,
                  or loose body sensations (meniscal displacement or IA loose body),

               2. Knee surgery on index knee within 12 months or on contralateral knee within 6
                  months, and/or

               3. Acute injury to the knee within 3 months.

          -  Subject has uncontrolled, unstable diabetes mellitus with HbA1C =/>8%.

          -  History within preceding 5 years of solid organ or hematologic transplantation or
             diagnosis of non-basal cell malignancy.

          -  History within the preceding 6 months of septic arthritis in the affected knee or
             sepsis/bacteremia.

          -  History within the preceding 3 months of infection requiring antibiotic treatment .
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment