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

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ClinicalTrials.gov Identifier: NCT04234412
Recruitment Status : Not yet recruiting
First Posted : January 21, 2020
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Seckjung Kim, Uijeongbu St. Mary Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: only case series of the treated patients
Primary Purpose: Treatment
Official Title: Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Osteoarthritic knee patients
Osteoarthritic Knee of the patients who will be treated wth high tibial osteotomy and implantation of allogenic human umbilical cord blood-derived stem cells.
 Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment

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.


Outcome Measures
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Primary Outcome Measures :
  1. International Cartilage Repair Society (ICRS) grade improvement [ Time Frame: at 24, 48, 96 weeks after surgery, score changes will be observed. ]
    over grade 1 should be improved


Secondary Outcome Measures :
  1. Visual analogue scale (VAS) [ Time Frame: at 24, 48, 96 weeks after surgery, score changes will be observed. ]
    0-10 score range, lower the better

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: at 24, 48, 96 weeks after surgery, score changes will be observed. ]
    0-100 score range, lower the better

  3. International Knee Documentation Committee (IKDC score) [ Time Frame: at 24, 48, 96 weeks after surgery, score changes will be observed. ]
    0-100 % range, lower the better


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Seckjung Kim, Professor, Uijeongbu St. Mary Hospital
ClinicalTrials.gov Identifier: NCT04234412    
Other Study ID Numbers: UC19OISI0134
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: according to patient agreement, this is flexible.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seckjung Kim, Uijeongbu St. Mary Hospital:
osteoarthritis
knee
high tibial osteotomy
umbilical cord blood stem cell
cartilage regeneration
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases