Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis.

Kaohsiung Veterans General Hospital

Status

Unknown

Conditions

Knee Osteoarthristis

Treatments

Biological: Human amniotic suspension allograft (ASA)

Study type

Interventional

Funder types

Other

Identifiers

NCT04698265

KSVGH20-CT9-11, ASA RCT 1.0

Details and patient eligibility

About

A double-blind, randomized controlled trial designed to evaluate the symptomatic modulating efficacy of amniotic suspension allograft (ASA) in comparison to platelet-rich plasma (PRP), hyaluronic acid (HA) and normal saline (NS) in the injection treatment of knee osteoarthritis. The hypothesis is that ASA would provide the greatest functional improvement.

Full description

At least 150 subjects with osteoarthritic knee will be recruited and computer randomized 1:1:1:1 to single injection of ASA (40mg), ASA (20mg), PRP + HA, and NS groups. Both subjects and evaluaters were blinded to allocations. Functional and radiologic outcomes were measured at baseline, and 1 week, 1, 3, 6, 12 months postinjection.

Enrollment

150 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 20 and 80 years
Ability to provide informed consent
Unilateral or bilateral knee VAS pain score ≥ 4 of 10 (worst possible pain) for more than 4 months
Diagnosis of OA Kellgren-Lawrence I-III by radiography (triple-film of bilateral lower limb, standard knee anterior-posterior view in full extension, lateral view in 30-degrees flexion, and 45°Merchant views)
No prior PRP injection of knee
No prior surgical procedure of the participating knee
BMI<40 kg/m2

Exclusion criteria

Lawrence stage IV
Major axial deviation (varus> 5°, valgus > 5°)
Any concomitant symptomatic knee disorder (i.e. ligamentous/ meniscal injury)
Systemic inflammatory arthropathy
Hematologic diseases
Severe cardiovascular disease
Neurological disorders
Active infection
Immuno-compromised
Therapy with anticoagulants or antiaggregants
Use of NSAIDs and/or chondroprotective supplements, such as glucosamines and chondroitin sulfates, within 7 days prior to trial
Recent intra-articular injection of corticosteroids (within 30 days)
Prior treatment with HA in past 6 monthsHb< 11 g/dL
Platelet count < 150,000/mm3

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 4 patient groups, including a placebo group

Human amniotic suspension allograft (ASA), 40 mg

Experimental group

Description:

Human amniotic suspension allograft (ASA) contains particulated human amniotic membrane and cells derived from the amniotic fluid. The allograft is freeze-dried, terminally sterilized with low dose gamma irradiation. Arm 1 uses 40 mg ASA stored in a sterile vial (Amniogen, HTC Regenerative Ltd. New Taipei, Taiwan).

Treatment:

Biological: Human amniotic suspension allograft (ASA)

Human amniotic suspension allograft (ASA), 20 mg

Experimental group

Description:

Human amniotic suspension allograft (ASA) contains particulated human amniotic membrane and cells derived from the amniotic fluid. The allograft is freeze-dried, terminally sterilized with low dose gamma irradiation. Arm 2 uses 20 mg ASA stored in a sterile vial (Amniogen, HTC Regenerative Ltd. New Taipei, Taiwan).

Treatment:

Biological: Human amniotic suspension allograft (ASA)

CellularMatrix (a combination of platelet-rich plasma and hyaluronic acid)

Experimental group

Description:

CellularMatrix (RegenLab SA, Switzerland) is composed of sterile and non-pyrogenic tubes allowing the mix of Platelet Rich Plasma (PRP) with Hyaluronic Acid (HA) in the same proportion (2mL of PRP for 2mL of HA).

Treatment:

Biological: Human amniotic suspension allograft (ASA)

Normal saline

Placebo Comparator group

Description:

4ml of normal saline

Treatment:

Biological: Human amniotic suspension allograft (ASA)