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

Samsung Medical Center

Status and phase: Unknown; Early Phase 1

Conditions: Osteochondral Lesion of Talus

Treatments: Biological: Cartistem

Study type: Interventional

Funder types: Other

Identifiers

NCT02338375

2012-10-078

Details and patient eligibility

About

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.

Full description

same as above

Enrollment: 28 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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
• Participants of other clinical trial within 4 weeks
• Patients treated with immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
• Unstable ankle joint(lesion site) greater than grade II at physical exam (Grade 0 : none, grade Ⅰ: 0~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜)
• Other inappropriate patients determined by the prinicipal investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Cartistem

Experimental group

Description:

For control group patients currently standard treatment of arthroscopic curettage and microfracture is performed, and for study group patients allogenic umbilical cord blood-derived mesenchymal stem cell product(Cartistem®) is added on the lesion after above mentioned procedure.

Treatment:

Biological: Cartistem

standard treatment

Active Comparator group

Description:

standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus

Treatment:

Biological: Cartistem