Clinical Trial of the Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product With Microfracture for Osteochondral Lesion of Talus Patients

Samsung Medical Center1 site in 1 country28 target enrollmentDecember 2012

ConditionsOsteochondral Lesion of Talus

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Osteochondral Lesion of Talus
Sponsor: Samsung Medical Center
Enrollment: 28
Locations: 1
Primary Endpoint: evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by American Orthopaedic Foot and Ankle Society(AOFAS) HINDFOOT/ANKLE SCALE
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus.

Detailed Description

same as above

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

December 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

ChulWon Ha

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•Non-responder to conservative treatment for radiographically confirmed (by MRI) osteochondral lesion of talus with ankle pain and/or stiffness and less than 75 of the AOFAS score
•Age between 20 and 70 year-old
•Appropriate function of blood clot PT(INR) \< 1.5, APTT \<1.5×control
•Appropriate renal function Creatinine ≤ 2.0 ㎎/㎗, proteinuria less than trace with Dipstick urine test
•Appropriate hepatic function Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
•No evidence of autoimmue disorder As screening test anti-nuclear antibody and/or anti-thyroglobulin antibody, if positive rheumatologist referral needed to confirm diagnosis
•No surgery or radiotherapy for the same ankle joint within 6 weeks
•Female patients agreeing with maintenance of contraception during study period
•No ligament instability greater than grade II (Grade 0 : none, Grade Ⅰ: 0\~5㎜, GradeⅡ: 5\~10㎜, Grade Ⅲ: \>10㎜) with physical exam
•Patients agreeing with participation in this study and signed on informed consent by their own will

Exclusion Criteria

•Degenerative ankle arthritis patients
•Patients with autoimmune disease
•Patients with infectious disease needed parenteral antibiotics
•Patients with myocardial infarction, congestive heart failure, other serious heart diseases or uncontrollable hypertion
•Patients with other serious medical illness
•Pregnancy or breast feeding patients
•Past history related with psychiatric illness or epilepsy
•Alcoholic abuse
•Heavy smoker
•Chronic inflammatory disease including rheumatoid arthritis

Outcomes

Primary Outcomes

evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by American Orthopaedic Foot and Ankle Society(AOFAS) HINDFOOT/ANKLE SCALE

Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48

Secondary Outcomes

evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by 100-mm VAS(Visual Analogue Scale)(Baseline, Week 4, Week 8, Week 12, Week 24, Week 48)