Amniotic Suspension Allograft Injection for Knee Osteoarthritis

MI-összefoglaló

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The trial is looking for adults with knee osteoarthritis (wear-and-tear arthritis of the knee) that causes pain. It compares two doses of an amniotic tissue injection with hyaluronic acid and salt-water injections.

Életkor

18 to 80 years

Nem

All sexes

A betegség stádiuma

Knee osteoarthritis with symptoms, grade 2 or 3 on the Kellgren-Lawrence X-ray scale. Pain score above 4 (scale 1 to 10) over the past 7 days. Able to walk alone or with a cane. Body mass index (BMI) under 40 kg/m².

Korábbi kezelés

No corticosteroid or visco-supplementation injection into the affected knee in the 3 months before joining. No pain medicines except acetaminophen in the 15 days before the injection. No surgery on the affected knee in the past 12 months, or on the other knee in the past 6 months.

A részvétel fő kizáró okai

• Pregnant women or women planning a pregnancy
• Regular use of blood thinners (anticoagulants) or current use of medicines that weaken the immune system
• History of organ or blood stem cell transplant
• Cancer diagnosed in the past 5 years, except treated basal cell skin cancer
• History of substance abuse

A regiszter feltételei, szó szerint

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Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 18 és 80 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 4 csoportja

• ASA injection 40 mg groupA vizsgált kezelés

  AMNIOGEN® 40mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline.

• ASA injection 20 mg groupA vizsgált kezelés

  AMNIOGEN® 20mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline.

• HA injection groupMár használt kezelés, összehasonlításként

  3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan)

• Normal saline injection groupPlacebo, összehasonlításként

  3 ml of sterile normal saline