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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02755376
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 59
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Deficiency of Anterior Cruciate Ligament	Biological: Cartistem(TM); Biological: hyaluronic acid; Procedure: ACL reconstruction only	N/A

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

1. Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between bone tunnel and graft in ACL reconstruction.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Apr 28, 2016
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ACL reconstruction only only ACL reconstruction without any injection	Procedure: ACL reconstruction only; ACL reconstruction only without any injection under arthroscopy
Experimental: ACL reconstruction + Cartistem(TM) ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.	Biological: Cartistem(TM); ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.; Procedure: ACL reconstruction only; ACL reconstruction only without any injection under arthroscopy
Experimental: ACL reconstruction + Hyaluronic acid ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy	Biological: hyaluronic acid; ACL reconstruction and injection of hyaluronic acid under arthroscopy.; Procedure: ACL reconstruction only; ACL reconstruction only without any injection under arthroscopy

Outcome Measures

Primary Outcome Measures

1. Bone formation on interface between bone tunnel and graft [Changes at 12 week, 24 week, 48 week after surgery]

Secondary Outcome Measures

1. Arthroscopic grading of graft [48 week after surgery]

2. Telos stress X-ray [Changes at 12 week, 24 week, 48 week after surgery]

3. KT-2000 [Changes at 12 week, 24 week, 48 week after surgery]

4. clinical knee scoring [Changes at 12 week, 24 week, 48 week after surgery]

5. Instability assessing with physical examination [Changes at 12 week, 24 week, 48 week after surgery]

6. Tunnel enlargement after anterior cruciate ligament reconstruction [Changes at 12 week, 24 week, 48 week after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Study Chair: Joon Ho Wang, MD, Ph D, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02755376
• Other Study ID Numbers: SMC 2013-07-117-002
• First Posted: Apr 28, 2016
• Last Update Posted: Apr 10, 2019
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Hyaluronic Acid

Study Results

No Results Posted as of Apr 10, 2019