Amniotic Suspension Allograft Injection for Knee Osteoarthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChang Gung Memorial Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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 (KL) grading scale.
Numerical Rating Scale (NRS) score (scale 1 to 10) for pain greater than 4 over the past 7 days.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ASA injection 40 mg group
DrugParticipants will receive intra-articular knee injections under ultrasound guidance with AMNIOGEN® 40mg (HCT Regenerative, New Taipei, Taiwan) diluted in 3.0 mL of sterile normal saline.
ASA injection 20 mg group
DrugParticipants will receive intra-articular knee injections under ultrasound guidance with AMNIOGEN® 20mg (HCT Regenerative, New Taipei, Taiwan) diluted in 3.0 mL of sterile normal saline.
HA injection group
DrugParticipants will receive intra-articular knee injections under ultrasound guidance with 3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan).
Normal saline injection group
DrugParticipants will receive intra-articular knee injections under ultrasound guidance with 3 ml of sterile normal saline.
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: ASA injection 40 mg groupExperimental treatment 1 intervention
Group B: ASA injection 20 mg groupExperimental treatment 1 intervention
Group C: HA injection groupActive comparator 1 intervention
Group D: Normal saline injection groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS)
This scale assesses overall pain severity, with scores ranging from 0 (no pain) to 10 (severe pain). Measurements will be taken before treatment and at 1, 3, 6, and 12 months after treatment.
Time frame
From enrollment to the end of study at 12 months2
Knee Injury and Osteoarthritis Outcome Score (KOOS)
This questionnaire measures knee injury and osteoarthritis impact across five domains: pain, symptoms, activities of daily living (ADL), sport and recreation function, and quality of life. Measurements will be collected at baseline and at 1, 3, 6, and 12 months post-treatment. The resulting scores are transformed to a scale from 0 (extreme knee problems) to 100 (no knee problems).
Time frame
From enrollment to the end of study at 12 months3
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
This quality-of-life assessment, developed by the World Health Organization, evaluates four domains: physical health, psychological well-being, social relationships, and environment. It will be administered before treatment and at 1, 3, 6, and 12 months post-treatment. The score of each domain ranges from 0 (worst outcome) to 100 (best outcome). The total score is the summation of each domain score.
Time frame
From enrollment to the end of study at 12 monthsSecondary outcomes
1
Number of participants with abnormal Complete Blood Count (CBC)
Each participant will undergo blood tests for Complete Blood Count (CBC) before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. Complete Blood Count (CBC) includes 1. WBC in 1000/μL 2. RBC in million/μL 3. Hemoglobin in g/dL 4. Hematocrit in % 5. MCV in fL 6. MCH in pg/cell 7. MCHC in g/dL 8. RDW in % 9. RDW-SD in fL 10. Platelet in 1000/μL 11. PDW in fL 12. MPV in fL All blood samples will be analyzed at the laboratory of Chang Gung Memorial Hospital. The investigators will count the number of participants with abnormal CBC.
Time frame
From enrollment to the end of study at 12 months2
C-reactive protein (CRP)
Each participant will undergo blood test for C-reactive protein (CRP in mg/L) before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. All blood samples will be analyzed at the laboratory of Chang Gung Memorial Hospital.
Time frame
From enrollment to the end of study at 12 months3
Erythrocyte Sedimentation Rate (ESR)
Each participant will undergo blood test for Erythrocyte Sedimentation Rate (ESR in mm/hr) before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. All blood samples will be analyzed at the laboratory of Chang Gung Memorial Hospital.
Time frame
From enrollment to the end of study at 12 months4
Cytokine IL-6
Each participant will undergo blood test for cytokine IL-6 in pg/mL before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. All blood samples will be analyzed at the laboratory of Chang Gung Memorial Hospital.
Time frame
From enrollment to the end of study at 12 monthsSponsors and contacts
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Source ClinicalTrials.gov