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

Sponsor
Samsung Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02338375
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
36
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Cartistem
 Early Phase 1

Detailed Description

same as above

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Study Start Date :
Dec 1, 2012
Anticipated Primary Completion Date :
Aug 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cartistem

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.

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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]

Secondary Outcome Measures

  1. 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]

Other Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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: 05㎜, GradeⅡ: 510㎜, 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: 05㎜, GradeⅡ: 510㎜, Grade Ⅲ: >10㎜)

  • Other inappropriate patients determined by the prinicipal investigator

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Gangnam-Gu Seoul Korea, Republic of 135-710

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ChulWon Ha, MD, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02338375
Other Study ID Numbers:
  • 2012-10-078
First Posted:
Jan 14, 2015
Last Update Posted:
Jan 14, 2015
Last Verified:
Jan 1, 2015

Study Results

No Results Posted as of Jan 14, 2015