Injection of amniotic suspension allograft for knee osteoarthritis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kaohsiung Chang Gung Memorial Hospital
  Kaohsiung, Taiwan, Taiwan Recruiting
• Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
  Kaohsiung City, Taiwan Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.