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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

Tracking Information
First Submitted Date  ICMJE January 5, 2020
First Posted Date  ICMJE January 21, 2020
Last Update Posted Date January 21, 2020
Estimated Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
Official Title  ICMJE Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
only case series of the treated patients
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE 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.

Study Arms  ICMJE 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.
Intervention: Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04234412
Other Study ID Numbers  ICMJE UC19OISI0134
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: according to patient agreement, this is flexible.
Responsible Party Seckjung Kim, Uijeongbu St. Mary Hospital
Study Sponsor  ICMJE Uijeongbu St. Mary Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Uijeongbu St. Mary Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP