Clinical trial NCT02755376: Development of Novel Strategy for Treatment of Anterior Cruciate Ligament (ACL) Injury Using Stem Cell
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency of Anterior Cruciate Ligament
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Bone formation on interface between bone tunnel and graft
timeFrame: Changes at 12 week, 24 week, 48 week after surgery
Secondary outcomes:
measure: Arthroscopic grading of graft
timeFrame: 48 week after surgery
measure: Telos stress X-ray
timeFrame: Changes at 12 week, 24 week, 48 week after surgery
measure: KT-2000
timeFrame: Changes at 12 week, 24 week, 48 week after surgery
measure: clinical knee scoring
timeFrame: Changes at 12 week, 24 week, 48 week after surgery
measure: Instability assessing with physical examination
timeFrame: Changes at 12 week, 24 week, 48 week after surgery
measure: Tunnel enlargement after anterior cruciate ligament reconstruction
timeFrame: Changes at 12 week, 24 week, 48 week after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Joon Ho Wang, MD, Ph D
role: STUDY_CHAIR
References: