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

Samsung Medical Center1 site in 1 country30 target enrollmentJanuary 1, 2014

ConditionsDeficiency of Anterior Cruciate Ligament

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Deficiency of Anterior Cruciate Ligament
Sponsor: Samsung Medical Center
Enrollment: 30
Locations: 1
Primary Endpoint: Bone formation on interface between bone tunnel and graft
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2014

End Date

December 1, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Degenerative osteoarthritis in knee
•Revision or other surgery history (stem cell treatment)
•Chronic inflammatory joint disease like rheumatoid arthritis
•Infectious disease need to administration of parenteral antibiotics
•Autoimmune disease
•Myocardial infarction, congestive heart failure, other serious heart disease
•Uncontrolled hypertension
•Serious medical disease
•Pregnancy and breast-feeding
•psychiatric disorder and epilepsy

Outcomes

Primary Outcomes

Bone formation on interface between bone tunnel and graft

Time Frame: Changes at 12 week, 24 week, 48 week after surgery

Secondary Outcomes

Arthroscopic grading of graft(48 week after surgery)
Instability assessing with physical examination(Changes at 12 week, 24 week, 48 week after surgery)
Tunnel enlargement after anterior cruciate ligament reconstruction(Changes at 12 week, 24 week, 48 week after surgery)
Telos stress X-ray(Changes at 12 week, 24 week, 48 week after surgery)
KT-2000(Changes at 12 week, 24 week, 48 week after surgery)
clinical knee scoring(Changes at 12 week, 24 week, 48 week after surgery)