Amniotic Suspension Allograft Injection for Knee Osteoarthritis

Launched by CHANG GUNG MEMORIAL HOSPITAL · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for knee osteoarthritis using a special injection called amniotic suspension allograft (ASA). Osteoarthritis is a common condition that causes pain and stiffness in the knees. The study aims to compare how effective ASA is compared to another injection called hyaluronic acid (HA) and a saline solution (a simple saltwater) in reducing pain and improving the quality of life for those suffering from knee osteoarthritis. Researchers are also trying to find out if different doses of ASA might work better than others.

To participate in this trial, you need to be between 18 and 80 years old, have a body mass index (BMI) of less than 40, and experience moderate to severe knee pain. You should be able to walk on your own or with a cane. However, pregnant women, those taking certain medications, or individuals with specific medical histories may not be eligible. If you choose to join, you will receive one of the injections and will be monitored for its effects on your knee pain over time. This trial is important because it could help find new, effective treatments for knee osteoarthritis that can provide relief without the need for surgery.

Gender

ALL

Eligibility criteria

• 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).