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

NCT04698265 | Unknown DMC

• 1 other identifier: KSVGH20-CT9-11, ASA RCT 1.0
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Knee Osteoarthristis

Outcome Measures

Primary Outcomes (1)

• Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 1 ,3 ,6 ,12 months.

  WOMAC is a self-administered questionnaire consisting of 24 items divided into 3 subscales:(1) Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright(2) Stiffness (2 items): after first waking and later in the day(3) Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic dutiesThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

  Baseline, 1 week, 1,3,6,12 months

Secondary Outcomes (1)

• Change of the International Knee Documentation Committee (IKDC Questionnaire) between baseline, 1 week, and 1 ,3 ,6 ,12 months.

  Baseline, 1 week, 1,3,6,12 months

Study Arms (4)

Human amniotic suspension allograft (ASA), 40 mg

EXPERIMENTAL

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).

Biological: Human amniotic suspension allograft (ASA)

Human amniotic suspension allograft (ASA), 20 mg

EXPERIMENTAL

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).

Biological: Human amniotic suspension allograft (ASA)

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

EXPERIMENTAL

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).

Biological: Human amniotic suspension allograft (ASA)

Normal saline

PLACEBO COMPARATOR

4ml of normal saline

Biological: Human amniotic suspension allograft (ASA)

Interventions

Human amniotic suspension allograft (ASA) BIOLOGICAL

Human amniotic suspension allograft (ASA) intra-articular injection.

CellularMatrix (a combination of platelet-rich plasma and hyaluronic acid); Human amniotic suspension allograft (ASA), 20 mg; Human amniotic suspension allograft (ASA), 40 mg; Normal saline

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Central Study Contacts

Kuan-Yu Lin

CONTACT

+886-7-3422121; johnkyl@yahoo.com

Yin-Ming Huang

CONTACT

+886-7-3422121; rex781104@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief resident of Orthopedic.

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: January 6, 2021
• Study Start: January 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2023
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share