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

Osteochondral Lesion of Talus Clinical Trial

— Cartistem  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02338375
• Other study ID #: 2012-10-078
• Status: Enrolling by invitation
• Phase: Phase 0
• First received: July 31, 2013
• Last updated: January 11, 2015
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

same as above

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 ?: 0~5?, Grade?:

5~10?, Grade ?: >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 ?: 0~5?, Grade?: 5~10?, Grade ?: >10?)

• Other inappropriate patients determined by the prinicipal investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteochondral Lesion of Talus

Intervention

Biological:
• Cartistem
Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Gangnam-Gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by ICRS arthroscopic scale for repair of articular cartilage		Baseline, Week 4, Week 8, Week 12, Week 24, Week 48	No
Primary	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		Baseline, Week 4, Week 8, Week 12, Week 24, Week 48	No
Secondary	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	No