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Development of Novel Strategy for Treatment of Anterior Cruciate Ligament (ACL) Injury Using Stem Cell

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: NCT02755376
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE February 22, 2015
First Posted Date  ICMJE April 28, 2016
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE January 1, 2014
Actual Primary Completion Date April 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
Bone formation on interface between bone tunnel and graft [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02755376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
  • Arthroscopic grading of graft [ Time Frame: 48 week after surgery ]
  • Telos stress X-ray [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
  • KT-2000 [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
  • clinical knee scoring [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
  • Instability assessing with physical examination [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
  • Tunnel enlargement after anterior cruciate ligament reconstruction [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
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 Development of Novel Strategy for Treatment of Anterior Cruciate Ligament (ACL) Injury Using Stem Cell
Official Title  ICMJE A Randomized, Single Center, Investigator Initiated Clinical Trial to Evaluate Enhancement of Healing Between Bone Tunnel and Graft in Anterior Cruciate Ligament (ACL) Injury Using Human Umbilical Cord Blood Derived Mesenchymal Stem Cell
Brief Summary Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
Detailed Description
  1. Purpose: Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
  2. Subject: Anterior cruciate ligament (ACL) injury 30 patients

    • ACL reconstruction: 10
    • ACL reconstruction + Human cord blood derived mesenchymal stem cells and hyaluronic acid (Cartistem (TM)): 10
    • ACL reconstruction + hyaluronic acid: 10
  3. Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between bone tunnel and graft in ACL reconstruction.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Deficiency of Anterior Cruciate Ligament
Intervention  ICMJE
  • Biological: Cartistem(TM)
    ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.
  • Biological: hyaluronic acid
    ACL reconstruction and injection of hyaluronic acid under arthroscopy.
  • Procedure: ACL reconstruction only
    ACL reconstruction only without any injection under arthroscopy
Study Arms  ICMJE
  • Active Comparator: ACL reconstruction only
    only ACL reconstruction without any injection
    Intervention: Procedure: ACL reconstruction only
  • Experimental: ACL reconstruction + Cartistem(TM)
    ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.
    Interventions:
    • Biological: Cartistem(TM)
    • Procedure: ACL reconstruction only
  • Experimental: ACL reconstruction + Hyaluronic acid
    ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy
    Interventions:
    • Biological: hyaluronic acid
    • Procedure: ACL reconstruction only
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2016)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date April 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 20~50
  2. Lachman test grade II,III or Pivot shift test grade I,II,III or ACL rupture in MRI
  3. prothrombin time (PT) (INR) <1.5, activated partial thromboplastin time (aPTT) <1.5 x control
  4. Creatinine ≤2.0 ㎎/㎗, protein uria(dipstick) ≤ trace
  5. Bilirubin ≤2.0 ㎎/㎗, aspartate aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤100 IU/L
  6. No surgery and radiation therapy in recent 6 weeks
  7. No pregnancy
  8. No combine ligament instability ≥ grade II in physical examination (grade 0: none, grade I: 0~5mm, grade II: 5~10mm, grade III: >10mm)
  9. voluntary singed a consent form

Exclusion Criteria:

  1. Degenerative osteoarthritis in knee
  2. Revision or other surgery history (stem cell treatment)
  3. Chronic inflammatory joint disease like rheumatoid arthritis
  4. Infectious disease need to administration of parenteral antibiotics
  5. Autoimmune disease
  6. Myocardial infarction, congestive heart failure, other serious heart disease
  7. Uncontrolled hypertension
  8. Serious medical disease
  9. Pregnancy and breast-feeding
  10. psychiatric disorder and epilepsy
  11. Alcohol overuse
  12. Smoking overuse
  13. Administration of immunosuppressive agents like Cyclosporin A or Azathioprine in recent 6 weeks prior screening test
  14. Patient participating in other clinical trials in recent 4 weeks
  15. Combined ligament instability ≥ grade II in physical test.
  16. No allergy history to gentamicin antibiotics
  17. Hypersensitivity patient to bovine protein, hyaluronic acid, and anesthetic agent
  18. Inappropriate patient judged by researcher.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02755376
Other Study ID Numbers  ICMJE SMC 2013-07-117-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: age, physical exam, lab, etc will be shared
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Joon Ho Wang, MD, Ph D Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date December 2018

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