Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Brief Summary:
Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.

Condition or disease Intervention/treatment Phase
Deficiency of Anterior Cruciate Ligament Biological: Cartistem(TM) Biological: hyaluronic acid Procedure: ACL reconstruction only Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : April 28, 2016
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ACL reconstruction only
only ACL reconstruction without any injection
Procedure: ACL reconstruction only
ACL reconstruction only without any injection under arthroscopy

Experimental: ACL reconstruction + Cartistem(TM)
ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.
Biological: Cartistem(TM)
ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.

Procedure: ACL reconstruction only
ACL reconstruction only without any injection under arthroscopy

Experimental: ACL reconstruction + Hyaluronic acid
ACL reconstruction and concomitant hyaluronic acid injection 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




Primary Outcome Measures :
  1. Bone formation on interface between bone tunnel and graft [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]

Secondary Outcome Measures :
  1. Arthroscopic grading of graft [ Time Frame: 48 week after surgery ]
  2. Telos stress X-ray [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
  3. KT-2000 [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
  4. clinical knee scoring [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
  5. Instability assessing with physical examination [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]
  6. Tunnel enlargement after anterior cruciate ligament reconstruction [ Time Frame: Changes at 12 week, 24 week, 48 week after surgery ]


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.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02755376


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Study Chair: Joon Ho Wang, MD, Ph D Samsung Medical Center

Layout table for additonal information
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02755376     History of Changes
Other Study ID Numbers: SMC 2013-07-117-002
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: age, physical exam, lab, etc will be shared
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents