UnknownEarly Phase 1

Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product

South Korea28 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 smo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48

Trial details

NCT IDNCT02338375

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08

View on ClinicalTrials.gov More Osteochondral Lesion of Talus trials

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.