Amniotic Suspension Allograft Injection for Knee Osteoarthritis

NCT06704893 | Recruiting Phase 3

• 1 other identifier: 202401278A3
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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

Knee; Osteoarthritis

Keywords

double-blind randomized controlled trial; amniotic suspension allograft injection; knee osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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.

  From enrollment to the end of study at 12 months

• 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).

  From enrollment to the end of study at 12 months

• 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.

  From enrollment to the end of study at 12 months

Secondary Outcomes (7)

• Number of participants with abnormal Complete Blood Count (CBC)

  From enrollment to the end of study at 12 months

• C-reactive protein (CRP)

  From enrollment to the end of study at 12 months

• Erythrocyte Sedimentation Rate (ESR)

  From enrollment to the end of study at 12 months

• Cytokine IL-6

  From enrollment to the end of study at 12 months

• Knee Ultrasound Imaging

  From enrollment to the end of study at 12 months

Study Arms (4)

ASA injection 40 mg group

EXPERIMENTAL

AMNIOGEN® 40mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline.

Drug: ASA injection 40 mg group

ASA injection 20 mg group

EXPERIMENTAL

AMNIOGEN® 20mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline.

Drug: ASA injection 20 mg group

HA injection group

ACTIVE COMPARATOR

3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan)

Drug: HA injection group

Normal saline injection group

PLACEBO COMPARATOR

3 ml of sterile normal saline

Drug: Normal saline injection group

Interventions

ASA injection 40 mg group DRUG

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.

ASA injection 40 mg group

ASA injection 20 mg group DRUG

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.

ASA injection 20 mg group

HA injection group DRUG

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

HA injection group

Normal saline injection group DRUG

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

Normal saline injection group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Corticosteroid or visco-supplementation injection into the affected knee within 3 months prior to enrollment.
• Knee surgery on the affected side within 12 months before enrollment, or surgery on the contralateral knee within 6 months before enrollment.
• \. 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).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan, 833, Taiwan

RECRUITING

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

Kaohsiung City, 833, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: November 26, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

TW (2)