Amniotic Suspension Allograft Injection for Knee Osteoarthritis

Summary

There have been few clinical trials on ASA for the treatment of knee osteoarthritis, and there is currently no literature reporting the optimal treatment dosage. Non-surgical treatment options include braces, weight loss, lifestyle changes, oral pain relievers, and intra-articular injections. Recently, placental-derived tissues have gradually been applied in the treatment of knee osteoarthritis. These tissues were initially used primarily for burns, ulcers, and wounds that are difficult to heal, but have now begun to be utilized in the orthopedic field. They have been proven to contain various anti-inflammatory cytokines and growth factors, which can reduce inflammation associated with arthritis. Reducing inflammation not only alleviates the pain of knee osteoarthritis but also improves patients' quality of life. The purpose of this study is to compare the therapeutic effects of amniotic suspension allograft (ASA), hyaluronic acid (HA), and saline on knee osteoarthritis and to examine whether there is a dose-response relationship with ASA injections.

Eligibility

Inclusion Criteria:

1. Age between 18 and 80 years.
2. Body mass index (BMI) less than 40 kg/m².
3. Symptomatic knee osteoarthritis with X-ray evidence graded 2 or 3 on the Kellgren-Lawrence (KL) grading scale.
4. Numerical Rating Scale (NRS) score (scale 1 to 10) for pain greater than 4 over the past 7 days.
5. Able to walk independently or with the aid of a cane.

Exclusion Criteria:

1. Pregnant women or women planning pregnancy.
2. Regular use of anticoagulants.
3. Use of pain medications (except acetaminophen) within 15 days prior to injection.
4. History of substance abuse.
5. Patients who take additional knee symptom-relief medications during the study must report it to the research team; failure to comply will result in exclusion.
6. Corticosteroid or visco-supplementation injection into the affected knee within 3 months prior to enrollment.
7. Knee surgery on the affected side within 12 months before enrollment, or surgery on the contralateral knee within 6 months before enrollment.

9\. History of organ or hematopoietic stem cell transplant. 11. Current use of immunosuppressive agents. 12. Diagnosis of cancer within the past 5 years (except for treated basal cell carcinoma).

Conditions3

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