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

Deficiency of Anterior Cruciate Ligament Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755376
• Other study ID #: SMC 2013-07-117-002
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2018
• Est. primary completion date: April 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deficiency of Anterior Cruciate Ligament

Intervention

Biological:
• Cartistem(TM)
ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.
• hyaluronic acid
ACL reconstruction and injection of hyaluronic acid under arthroscopy.

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone formation on interface between bone tunnel and graft		Changes at 12 week, 24 week, 48 week after surgery
Secondary	Arthroscopic grading of graft		48 week after surgery
Secondary	Telos stress X-ray		Changes at 12 week, 24 week, 48 week after surgery
Secondary	KT-2000		Changes at 12 week, 24 week, 48 week after surgery
Secondary	clinical knee scoring		Changes at 12 week, 24 week, 48 week after surgery
Secondary	Instability assessing with physical examination		Changes at 12 week, 24 week, 48 week after surgery
Secondary	Tunnel enlargement after anterior cruciate ligament reconstruction		Changes at 12 week, 24 week, 48 week after surgery