NCT02755376

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2016

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 10, 2019

Status Verified

December 1, 2018

Enrollment Period

2.3 years

First QC Date

February 22, 2015

Last Update Submit

April 8, 2019

Conditions

Deficiency of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

  • Bone formation on interface between bone tunnel and graft

    Changes at 12 week, 24 week, 48 week after surgery

Secondary Outcomes (6)

  • Arthroscopic grading of graft

    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

  • Instability assessing with physical examination

    Changes at 12 week, 24 week, 48 week after surgery

  • +1 more secondary outcomes

Study Arms (3)

ACL reconstruction only

ACTIVE COMPARATOR

only ACL reconstruction without any injection

Procedure: ACL reconstruction only

ACL reconstruction + Cartistem(TM)

EXPERIMENTAL

ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy.

Biological: Cartistem(TM)Procedure: ACL reconstruction only

ACL reconstruction + Hyaluronic acid

EXPERIMENTAL

ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy

Biological: hyaluronic acidProcedure: ACL reconstruction only

Interventions

Cartistem(TM)BIOLOGICAL

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

ACL reconstruction + Cartistem(TM)
hyaluronic acidBIOLOGICAL

ACL reconstruction and injection of hyaluronic acid under arthroscopy.

ACL reconstruction + Hyaluronic acid
ACL reconstruction onlyPROCEDURE

ACL reconstruction only without any injection under arthroscopy

ACL reconstruction + Cartistem(TM)ACL reconstruction + Hyaluronic acidACL reconstruction only

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Joon Ho Wang, MD, Ph D

    Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2015

First Posted

April 28, 2016

Study Start

January 1, 2014

Primary Completion

April 28, 2016

Study Completion

December 1, 2018

Last Updated

April 10, 2019

Record last verified: 2018-12

Locations

KR(1)