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

Not Applicable

Completed

• Conditions: Deficiency of Anterior Cruciate Ligament
• Interventions: Procedure: ACL reconstruction only; Biological: hyaluronic acid; Biological: Cartistem(TM)

• Registration Number: NCT02755376
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2015-02-22
• Study First Submitted QC: 2016-04-25
• Primary Completion: 2016-04-28
• Study First Posted: 2016-04-28
• Status Verified: 2018-12
• Study Completion: 2018-12-01
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACL reconstruction only	ACL reconstruction only	only ACL reconstruction without any injection
ACL reconstruction + Hyaluronic acid	hyaluronic acid	ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy
ACL reconstruction + Cartistem(TM)	Cartistem(TM)	ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.
ACL reconstruction + Cartistem(TM)	ACL reconstruction only	ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.
ACL reconstruction + Hyaluronic acid	ACL reconstruction only	ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy

Primary Outcome Measures

Name	Time	Method
Bone formation on interface between bone tunnel and graft	Changes at 12 week, 24 week, 48 week after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of