NCT02338375

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2012

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

2.7 years

First QC Date

July 31, 2013

Last Update Submit

January 11, 2015

Conditions

Osteochondral Lesion of Talus

Outcome Measures

Primary Outcomes (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 Outcomes (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 Outcomes (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

Study Arms (2)

Cartistem

EXPERIMENTAL

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

standard treatment

ACTIVE COMPARATOR

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

Biological: Cartistem

Interventions

CartistemBIOLOGICAL

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

Cartistemstandard treatment

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Gangnam-Gu, Seoul, 135-710, South Korea

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 31, 2013

First Posted

January 14, 2015

Study Start

December 1, 2012

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

KR(1)