The Efficacy of Amniotic Suspension Allograft Injection in the Treatment of Knee Osteoarthritis: a Randomized Double-blind Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• Able to walk independently or with the aid of a cane.

Locations
Other Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 160
Treatments
Experimental: ASA injection 40 mg group
AMNIOGEN® 40mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline.
Experimental: ASA injection 20 mg group
AMNIOGEN® 20mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline.
Active_comparator: HA injection group
3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan)
Placebo_comparator: Normal saline injection group
3 ml of sterile normal saline
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov