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Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04310215
Recruitment Status : Enrolling by invitation
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
Medipost Co Ltd.
Information provided by (Responsible Party):
SK bioland co., ltd.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of adding CARTISTEM®(allogenic umbilical cord blood-derived stem cell product) on microfracture, a currently standard treatment for OLT, in patients with talar chondral or osteochondral defect.

Condition or disease Intervention/treatment Phase
Chondral or Osteochondral Lesion of Talus Biological: CARTISTEM® Procedure: Microfracture Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multicenter, Single-blinded, Stratified randomized
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Single-blind, Randomized, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adding CARTISTEM® on Microfracture in Patients With Talar Chondral or Osteochondral Defect
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Microfracture + CARTISTEM®
CARTISTEM® is added on the lesion as a single dose of 500 ㎕/㎠ according to the defect size after arthroscopic curettage and microfracture.
Biological: CARTISTEM®

*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠

  1. Procedure: Microfracture
  2. Biological: CARTISTEM®(Human Umbilical Cord Blood-derived Mesenchymal Stem Cell product)

Active Comparator: Microfracture
Standard treatment of arthroscopic curettage and microfracture is performed for cartilage defect.
Procedure: Microfracture

*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠

1. Procedure: Microfracture





Primary Outcome Measures :
  1. ICRS-Cartilage Repair Assessment Total Score [ Time Frame: Week 48 ]

    Arthroscopic evaluation of articular cartilage repair

    : The score range from 12(normal) to 1(severely abnormal) where lower scores indicate more severity of injury



Secondary Outcome Measures :
  1. ICRS-Cartilage Repair Assessment Overall Grade [ Time Frame: Week 48 ]
    The grades range from 1(normal) to 4 (severely abnormal) where lower grades indicate more complete repair

  2. Improvement degree of Cartilage Repair by MRI [ Time Frame: Week 0 and 48 ]

    Changes in MOCART(Magnetic resonance Observation of Cartilage Repair Tissue) score

    : MOCART score is a 9-part and 29-item scoring system, also resulting in a find cartilage repair tissue score between 0 and 100 points. 100 points represent the best imaginable score


  3. Degree of Functional improvement in FAOS(Foot & Ankle Outcome Score) [ Time Frame: Week 0, 24 and 48 ]
    : FAOS consists in 42 items that cover 5 dimensions (symptoms, pain, activities of daily living, sport and recreation activities, and quality of life. Raw scores of each sub-scales results of the sum of each items. A normalized score (100 indicationg no symptoms and 0 indicating extreame sysmptoms) is calculated for each subscale

  4. Degree of Functional improvement in AOFAS(The American Orthopaedic Foot & Ankle Score) [ Time Frame: Week 0, 24 and 48 ]
    : AOFAS consists in 9 items that can be divided into 3 sub-scales (pain, function and alignment). 100 points of 1 to 100 represent no symptoms or impairments

  5. Degree of Functional improvement in Tegner activity score [ Time Frame: Week 0, 24 and 48 ]
    : Tegner activity represents the highest level of activity on scale of 0 to 10 that you are able to participate in currently . The higher values represent a better outcome

  6. Degree of Quality of Life improvement in SF-36(Short Form Health Survey-36) [ Time Frame: Week 0, 24 and 48 ]
    : SF-36 comprises 36 items divided into two components of physical health and mental health. Higher scores between 0 and 100 represent better health status

  7. Degree of pain improvement in 100 mm VAS(Visual Analogue Scale) [ Time Frame: Week 0, 24 and 48 ]
    • VAS represents higher scores mean higher pain
    • 0 mm (no pain) and 100 mm (worst pain)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. No response to conservative treatment for more than 12 weeks, talar chondral/osteochondral lesion radiographically confirmed by MRI, ankle joint pain/stiffness and an AOFAS score of 75 or below
  2. Ankle joint cartilage injury of defect of ICRS grade Ⅳ
  3. Male or female aged between 20 to 70
  4. A one-sided lesion
  5. Appropriate function of blood clot: PT(INR) < 1.5×ULN, aPTT <1.5×ULN
  6. Appropriate renal function: Creatinine ≤ 2.0 ㎎/㎗, Proteinuria ≤ trace
  7. Appropriate hepatic function: Total bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
  8. No evidence of auto-immune disorder: Anti-nuclear antibody and anti-thyroglobulin antibody negative (If positive, there are possible case according to rheumatologist's diagnostic opinion)
  9. No surgery or radiotherapy for the same ankle joint within 6 weeks
  10. Female patients agreeing with maintenance of contraception* during study period

    *hormone contraceptive, implants of intrauterine device or intrauterine system, double barrier contraception[Concurrent use of diaphragm or cervical occlusive cap and male condom], surgical sterilisation, etc.

  11. No chronic ligament instability more than grade Ⅲ (Grade 0: none, Grade Ⅰ: 1~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜)
  12. Patients agreeing with participation in this study and signed on informed consent by their own will

Exclusion Criteria:

  1. Degenerative arthritis in ankle(Kellgren Lawrence Grade 3-4)
  2. Autoimmune disease
  3. Infectious disease need to administration of parenteral antibiotics
  4. Myocardial infarction, congestive heart failure, other serious cardiac disorder or uncontrolled resistant hypertension
  5. Serious medical disease(Ex. Kidney disease such as chronic renal failure or Glomerulonephritis, etc., acute/chronic liver disease such as liver cirrhosis, fatty liver etc., medical history of malignancy*)

    *Complete remission status is possible.

  6. Pregnancy or breast-feeding
  7. Psychiatric history or epilepsy
  8. Alcohol abuse
  9. Heavy smoker
  10. Chronic inflammatory disease such as rheumatoid arthritis
  11. Participants other clinical trials within 4 weeks
  12. Administration of immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
  13. Patients with acute ligament injury and clinically significant chronic ligament instability
  14. Patients treated with surgery or cell therapy product for the same disease
  15. Patients with hypersensitivity or allergy history to bovine protein, hyaluronic acid and gentamicin
  16. Other inappropriate patients determined by the principal investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310215


Locations
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Korea, Republic of
Kyunghee University Medical Center
Seoul, Dongdaemun-gu, Korea, Republic of, 02447
Gangnam Severance Hospital
Seoul, Gangnam-gu, Korea, Republic of, 06273
Samsung Medical Center
Seoul, Gangnam-gu, Korea, Republic of, 06351
Korea University Guro Hospital
Seoul, Guro-gu, Korea, Republic of, 08308
Chungnam National University Hospital
Daejeon, Jung-gu, Korea, Republic of, 35015
Inha University Hospital
Incheon, Jung-gu, Korea, Republic of, 22332
Sponsors and Collaborators
SK bioland co., ltd.
Medipost Co Ltd.

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Responsible Party: SK bioland co., ltd.
ClinicalTrials.gov Identifier: NCT04310215    
Other Study ID Numbers: CARTISTEM_2019_01
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared to other researchers.

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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 SK bioland co., ltd.:
OLT
Talus
Chondral Lesion
Osteochondral Lesion
Human umbilical cord blood-derived stem cell
MSC
Mesenchymal stem cell