Actively Recruiting
Amniotic Suspension Allograft Injection for Knee Osteoarthritis
Led by Chang Gung Memorial Hospital · Updated on 2026-01-26
160
Participants Needed
2
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Amniotic Suspension Allograft Injection for Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Body mass index (BMI) less than 40 kg/m²
- Symptomatic knee osteoarthritis with X-ray evidence graded 2 or 3 on the Kellgren-Lawrence scale
- Pain score greater than 4 on the Numerical Rating Scale in the past 7 days
- Able to walk independently or with a cane
You will not qualify if you...
- Pregnant women or women planning pregnancy
- Regular use of anticoagulants
- Use of pain medications (except acetaminophen) within 15 days prior to injection
- History of substance abuse
- Taking additional knee symptom-relief medications during the study without reporting
- Corticosteroid or visco-supplementation injection into the affected knee within 3 months before enrollment
- Knee surgery on the affected side within 12 months or on the opposite knee within 6 months before enrollment
- History of organ or hematopoietic stem cell transplant
- Current use of immunosuppressive agents
- Diagnosis of cancer within the past 5 years (except treated basal cell carcinoma)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, Taiwan, 833
Actively Recruiting
2
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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