Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT06704893

Amniotic Suspension Allograft Injection for Knee Osteoarthritis

Led by Chang Gung Memorial Hospital · Updated on 2026-01-26

160

Participants Needed

2

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Amniotic Suspension Allograft Injection for Knee Osteoarthritis

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 scale
  • Pain score greater than 4 on the Numerical Rating Scale in the past 7 days
  • Able to walk independently or with a cane
Not Eligible

You will not qualify if you...

  • 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
  • Taking additional knee symptom-relief medications during the study without reporting
  • Corticosteroid or visco-supplementation injection into the affected knee within 3 months before enrollment
  • Knee surgery on the affected side within 12 months or on the opposite knee within 6 months before enrollment
  • History of organ or hematopoietic stem cell transplant
  • Current use of immunosuppressive agents
  • Diagnosis of cancer within the past 5 years (except treated basal cell carcinoma)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan, Taiwan, 833

Actively Recruiting

2

Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan, 833

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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