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

Samsung Medical Center

Status: Completed

Conditions: Deficiency of Anterior Cruciate Ligament

Treatments: Procedure: ACL reconstruction only; Biological: Cartistem(TM); Biological: hyaluronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02755376

SMC 2013-07-117-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

ACL reconstruction only

Active Comparator group

Description:

only ACL reconstruction without any injection

Treatment:

Procedure: ACL reconstruction only

ACL reconstruction + Cartistem(TM)

Experimental group

Description:

ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.

Treatment:

Procedure: ACL reconstruction only

Biological: Cartistem(TM)

ACL reconstruction + Hyaluronic acid

Experimental group

Description:

ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy

Treatment:

Procedure: ACL reconstruction only

Biological: hyaluronic acid