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Amniotic Suspension Allograft Injection for Knee Osteoarthritis

Study acronym: ASAIKO
StatusRecruiting
PhasePhase 3
Started2024-10-21
View on ClinicalTrials.gov ↗

Amendment history

2026-01-23
minor
Study Status, Study Description, Outcome Measures, Contacts/Locations v1
Primary completion date2025-10-01→2027-12-31
Completion date2026-10-01→2027-12-31
Secondary endpointsdetails revised at 1 of 7 entries
Study description-12 characters
[...] ons. Numerous clinical trials have supported this treatment option1-3option. However, the effectiveness of PRP treatment is partly depe [...] ulcers, and other difficult-to-heal wounds such as corneal ulcers4ulcers. More recently, these tissues have been applied in the orthopedic field5-7field. These products come in several formulations, some containi [...] tic fluid, amniotic fluid itself, or a combination of these components8components. Placental tissues have been shown to contain a variety of [...] elieved to reduce the inflammatory response associated with arthritis9,10arthritis. Reducing this inflammation [...]
Study sitescontacts updated at 1 of 2 sites
2024-11-19
minor
Original filing
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.
Trial Details
NCT Number NCT06704893
Lead Sponsor Chang Gung Memorial Hospital
Conditions Knee, Osteoarthritis
Enrollment 160 participants
Start Date 2024-10-21
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-26