Actively Recruiting
The Efficacy of Amniotic Suspension Allograft Injection in the Treatment of Knee Osteoarthritis: a Randomized Double-blind Controlled Trial
Led by Chang Gung Memorial Hospital · Updated on 2026-01-26
160
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of amniotic suspension allograft (ASA) injections compared to hyaluronic acid (HA) and saline injections for treating knee osteoarthritis in adults aged 18 to 80. This condition involves joint cartilage damage and inflammation leading to pain and decreased mobility. The study aims to find the best ASA dose and assess its potential to reduce inflammation and improve quality of life compared to existing injection treatments. Participants will be randomly assigned to receive one of four intra-articular knee injections under ultrasound guidance: ASA 40 mg, ASA 20 mg, HA, or saline. ASA injections are prepared by diluting AMNIOGEN® tissue in saline, while HA and saline are administered as per standard concentrations. The trial is double-blind, ensuring neither participants nor researchers know the assigned treatment. Injections and follow-up occur over a 12-month period. During the study, participants will undergo assessments including pain scales (VAS, NRS), knee injury and osteoarthritis outcome scores (KOOS), and quality of life evaluations (WHOQOL-BREF). Laboratory tests such as complete blood count, C-reactive protein, erythrocyte sedimentation rate, and cytokine levels will be monitored. Imaging with knee ultrasound and X-ray will assess joint status, alongside cartilage protein measurements. Safety and treatment effects will be observed throughout the 12 months of follow-up.
CONDITIONS
Brief 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 grading scale
- Numerical Rating Scale (NRS) pain score greater than 4 over the past 7 days
- Able to walk independently or with the aid of 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
- Use of additional knee symptom-relief medications during the study without reporting to the research team
- Corticosteroid or visco-supplementation knee injection within 3 months prior to enrollment
- Knee surgery on the affected side within 12 months before enrollment or surgery 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit with follow-up assessments up to 12 months
Participants receive intra-articular knee injections under ultrasound guidance with one of the study drugs: AMNIOGEN® 40mg, AMNIOGEN® 20mg, HyLink (HA), or sterile normal saline.
1 injection visit and multiple follow-up visits over 12 months
Duration - Up to 12 months
Participants are monitored for treatment effects, safety, and quality of life over 12 months after injection.
Multiple follow-up visits over 12 months
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here