Skip to main content
OpenTrials
Completed

NCT Number: NCT02755376

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deficiency of Anterior Cruciate Ligament

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cartistem(TM)

Biological

ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.

Hyaluronic Acid

Biological

ACL reconstruction and injection of hyaluronic acid under arthroscopy.

ACL reconstruction only

Procedure

ACL reconstruction only without any injection under arthroscopy

Primary outcomes

  1. Bone formation on interface between bone tunnel and graft

    Time frame: Changes at 12 week, 24 week, 48 week after surgery

Secondary outcomes

  1. Arthroscopic grading of graft

    Time frame: 48 week after surgery

  2. Telos stress X-ray

    Time frame: Changes at 12 week, 24 week, 48 week after surgery

  3. KT-2000

    Time frame: Changes at 12 week, 24 week, 48 week after surgery

  4. clinical knee scoring

    Time frame: Changes at 12 week, 24 week, 48 week after surgery

  5. Instability assessing with physical examination

    Time frame: Changes at 12 week, 24 week, 48 week after surgery

  6. Tunnel enlargement after anterior cruciate ligament reconstruction

    Time frame: Changes at 12 week, 24 week, 48 week after surgery

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Apr 28, 2016
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.