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Amniotic Suspension Allograft Injection for Knee Osteoarthritis

NCT06704893 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ASA injection 40 mg group

Participants 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.

DRUG

ASA injection 20 mg group

Participants 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.

DRUG

HA injection group

Participants will receive intra-articular knee injections under ultrasound guidance with 3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan).

DRUG

Normal saline injection group

Participants will receive intra-articular knee injections under ultrasound guidance with 3 ml of sterile normal saline.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06704893 on ClinicalTrials.gov