Injection of amniotic suspension allograft for knee osteoarthritis treatment
The Efficacy of Amniotic Suspension Allograft Injection in the Treatment of Knee Osteoarthritis: a Randomized Double-blind Controlled Trial
This study is testing if injections of amniotic suspension allograft can help people with knee osteoarthritis feel less pain and move better compared to other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 2 sites (Kaohsiung, Taiwan and 1 other locations) |
| Trial ID | NCT06704893 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of amniotic suspension allograft (ASA) injections compared to hyaluronic acid (HA) and saline in treating knee osteoarthritis. It is a double-blind randomized controlled trial involving participants aged 18 to 80 with symptomatic knee osteoarthritis. The study aims to determine the optimal dosage of ASA and its impact on reducing inflammation and improving pain and mobility. Participants will be monitored for their pain levels and overall quality of life throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 80 with symptomatic knee osteoarthritis and a pain score greater than 4.
Not a fit: Patients who are pregnant, regularly use anticoagulants, or have had recent knee surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective non-surgical option for alleviating pain and improving mobility in patients with knee osteoarthritis.
How similar studies have performed: Other studies have shown promising results with similar approaches using placental-derived tissues for orthopedic conditions, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Kaohsiung, Taiwan and 1 other locations
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung, Taiwan, Taiwan (Recruiting)
- Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.