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

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Samsung Medical Center

Status

Completed

Conditions

Deficiency of Anterior Cruciate Ligament

Treatments

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

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

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

  • Age 20~50
  • Lachman test grade II,III or Pivot shift test grade I,II,III or ACL rupture in MRI
  • prothrombin time (PT) (INR) <1.5, activated partial thromboplastin time (aPTT) <1.5 x control
  • Creatinine ≤2.0 ㎎/㎗, protein uria(dipstick) ≤ trace
  • Bilirubin ≤2.0 ㎎/㎗, aspartate aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤100 IU/L
  • No surgery and radiation therapy in recent 6 weeks
  • No pregnancy
  • No combine ligament instability ≥ grade II in physical examination (grade 0: none, grade I: 0~5mm, grade II: 5~10mm, grade III: >10mm)
  • voluntary singed a consent form

Exclusion criteria

  • Degenerative osteoarthritis in knee
  • Revision or other surgery history (stem cell treatment)
  • Chronic inflammatory joint disease like rheumatoid arthritis
  • Infectious disease need to administration of parenteral antibiotics
  • Autoimmune disease
  • Myocardial infarction, congestive heart failure, other serious heart disease
  • Uncontrolled hypertension
  • Serious medical disease
  • Pregnancy and breast-feeding
  • psychiatric disorder and epilepsy
  • Alcohol overuse
  • Smoking overuse
  • Administration of immunosuppressive agents like Cyclosporin A or Azathioprine in recent 6 weeks prior screening test
  • Patient participating in other clinical trials in recent 4 weeks
  • Combined ligament instability ≥ grade II in physical test.
  • No allergy history to gentamicin antibiotics
  • Hypersensitivity patient to bovine protein, hyaluronic acid, and anesthetic agent
  • Inappropriate patient judged by researcher.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

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:
Biological: Cartistem(TM)
Procedure: ACL reconstruction only
ACL reconstruction + Hyaluronic acid
Experimental group
Description:
ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy
Treatment:
Biological: hyaluronic acid
Procedure: ACL reconstruction only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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