NCT06704893 Amniotic Suspension Allograft Injection for Knee Osteoarthritis
| NCT ID | NCT06704893 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2024-10-21 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Frequently Asked Questions
Who can join the NCT06704893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06704893 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT06704893 currently recruiting?
Yes, NCT06704893 is actively recruiting participants. Visit ClinicalTrials.gov or contact Chang Gung Memorial Hospital to inquire about joining.
Where is the NCT06704893 trial being conducted?
This trial is being conducted at Kaohsiung, Taiwan, Kaohsiung City, Taiwan.
Who is sponsoring the NCT06704893 clinical trial?
NCT06704893 is sponsored by Chang Gung Memorial Hospital. The trial plans to enroll 160 participants.