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Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
umbilical cord blood stem cell implantation for osteoarthritis treatment
Sponsored by
Uijeongbu St. Mary Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, knee, high tibial osteotomy, umbilical cord blood stem cell, cartilage regeneration

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age older than 30 years,
  • full-thickness cartilage lesion measuring at least 2 cm2,
  • femoro-tibial angle (varus or valgus) 5°< in the mechanical axis

Exclusion Criteria:

  • ligament injuries (such as injuries of the anterior cruciate ligament and posterior cruciate ligament),
  • metabolic arthritis
  • infectious condition
  • psychosis
  • serious medical illness
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Osteoarthritic knee patients

    Arm Description

    Osteoarthritic Knee of the patients who will be treated wth high tibial osteotomy and implantation of allogenic human umbilical cord blood-derived stem cells.

    Outcomes

    Primary Outcome Measures

    International Cartilage Repair Society (ICRS) grade improvement
    over grade 1 should be improved

    Secondary Outcome Measures

    Visual analogue scale (VAS)
    0-10 score range, lower the better
    Western Ontario and McMaster Universities Arthritis Index (WOMAC)
    0-100 score range, lower the better
    International Knee Documentation Committee (IKDC score)
    0-100 % range, lower the better

    Full Information

    First Posted
    January 5, 2020
    Last Updated
    January 15, 2020
    Sponsor
    Uijeongbu St. Mary Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04234412
    Brief Title
    Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
    Official Title
    Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2020 (Anticipated)
    Primary Completion Date
    November 30, 2022 (Anticipated)
    Study Completion Date
    November 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Uijeongbu St. Mary Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint. This study will prospectively evaluate 10 knees after hUCB-MSCs implantation and High Tibial Osteotomy(HTO) in the medial compartment osteoarthritis and varus deformity of the knee joint. Clinical outcomes will be evaluated using the International Knee Documentation committee(IKDC), Visual analogue scale(VAS), Western Ontario and McMaster Universities Arthritis Index(WOMAC), and patients satisfaction with the surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    osteoarthritis, knee, high tibial osteotomy, umbilical cord blood stem cell, cartilage regeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    only case series of the treated patients
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Osteoarthritic knee patients
    Arm Type
    Experimental
    Arm Description
    Osteoarthritic Knee of the patients who will be treated wth high tibial osteotomy and implantation of allogenic human umbilical cord blood-derived stem cells.
    Intervention Type
    Procedure
    Intervention Name(s)
    umbilical cord blood stem cell implantation for osteoarthritis treatment
    Intervention Description
    The arthroscopic procedure is performed in the supine position after spinal anesthesia. Once the chondral lesion is identified through a standard anteromedial and lateral portal, meniscectomy, meniscal repair, and lateral retinacular release are performed if necessary. microfracture is performed using a microfracture awl. Once both the unstable cartilage and subchondral bone are removed in the lesion area and the sclerotic bone is peeled slightly by using a burr, hole(s) are created for implantation by using a drill bit(diameter 4; depth: 4mm). After implantation is performed in the hole by injecting the mixture of sodium hyaluronate and hUCB-MSCs, it is trimmed to the height of the surrounding articular surface.
    Primary Outcome Measure Information:
    Title
    International Cartilage Repair Society (ICRS) grade improvement
    Description
    over grade 1 should be improved
    Time Frame
    at 24, 48, 96 weeks after surgery, score changes will be observed.
    Secondary Outcome Measure Information:
    Title
    Visual analogue scale (VAS)
    Description
    0-10 score range, lower the better
    Time Frame
    at 24, 48, 96 weeks after surgery, score changes will be observed.
    Title
    Western Ontario and McMaster Universities Arthritis Index (WOMAC)
    Description
    0-100 score range, lower the better
    Time Frame
    at 24, 48, 96 weeks after surgery, score changes will be observed.
    Title
    International Knee Documentation Committee (IKDC score)
    Description
    0-100 % range, lower the better
    Time Frame
    at 24, 48, 96 weeks after surgery, score changes will be observed.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age older than 30 years, full-thickness cartilage lesion measuring at least 2 cm2, femoro-tibial angle (varus or valgus) 5°< in the mechanical axis Exclusion Criteria: ligament injuries (such as injuries of the anterior cruciate ligament and posterior cruciate ligament), metabolic arthritis infectious condition psychosis serious medical illness pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    according to patient agreement, this is flexible.

    Learn more about this trial

    Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.

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