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

Primary Purpose

Knee Osteoarthristis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Human amniotic suspension allograft (ASA)
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthristis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Human amniotic suspension allograft (ASA), 40 mg

    Human amniotic suspension allograft (ASA), 20 mg

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

    Normal saline

    Arm 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).

    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).

    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).

    4ml of normal saline

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Change of the International Knee Documentation Committee (IKDC Questionnaire) between baseline, 1 week, and 1 ,3 ,6 ,12 months.
    The International Knee Documentation Committee Questionnaire is a knee-specific patient-reported outcome measure.The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100, This final number is interpreted as a measure of function with higher scores representing higher levels of function.

    Full Information

    First Posted
    December 20, 2020
    Last Updated
    January 5, 2021
    Sponsor
    Kaohsiung Veterans General Hospital.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04698265
    Brief Title
    Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis.
    Official Title
    Comparison of the Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: A Prospective, Double-blind, Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    January 31, 2022 (Anticipated)
    Study Completion Date
    January 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kaohsiung Veterans General Hospital.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthristis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Human amniotic suspension allograft (ASA), 40 mg
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    Human amniotic suspension allograft (ASA), 20 mg
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    CellularMatrix (a combination of platelet-rich plasma and hyaluronic acid)
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    4ml of normal saline
    Intervention Type
    Biological
    Intervention Name(s)
    Human amniotic suspension allograft (ASA)
    Intervention Description
    Human amniotic suspension allograft (ASA) intra-articular injection.
    Primary Outcome Measure Information:
    Title
    Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 1 ,3 ,6 ,12 months.
    Description
    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).
    Time Frame
    Baseline, 1 week, 1,3,6,12 months
    Secondary Outcome Measure Information:
    Title
    Change of the International Knee Documentation Committee (IKDC Questionnaire) between baseline, 1 week, and 1 ,3 ,6 ,12 months.
    Description
    The International Knee Documentation Committee Questionnaire is a knee-specific patient-reported outcome measure.The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100, This final number is interpreted as a measure of function with higher scores representing higher levels of function.
    Time Frame
    Baseline, 1 week, 1,3,6,12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kuan-Yu Lin
    Phone
    +886-7-3422121
    Ext
    3051
    Email
    johnkyl@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yin-Ming Huang
    Phone
    +886-7-3422121
    Ext
    3051
    Email
    rex781104@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We do not have the plan to make individual participant data (IPD) available to other researchers.

    Learn more about this trial

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

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