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

January 11, 2015 updated by: ChulWon Ha, Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

same as above

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Gangnam-Gu, Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Week 4, Week 8, Week 12, Week 24, Week 48

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by ICRS arthroscopic scale for repair of articular cartilage
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
Baseline, Week 4, Week 8, Week 12, Week 24, Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

January 11, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 11, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-10-078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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