NCT01041001

Randomized, Open-Label, Multi-Center and Phase 3 Clinical Trial to Compare the Efficacy and Safety of Cartistem® and Microfracture in Patients With Knee Articular Cartilage Injury or Defect

Completed Phase 3 Last updated 18 April 2017

What this trial tests

Phase 3 trial testing Cartistem in Cartilage Injury in 104 participants. Completed in 1 January 2011.

Timeline

1 February 2009

Primary endpoint
1 December 2010

1 January 2011

Quick facts

Lead sponsor	Medipost Co Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	104
Start date	1 February 2009
Primary completion	1 December 2010
Estimated completion	1 January 2011
Sites	8 locations across South Korea

Drugs / interventions tested

• Cartistem — full drug profile →
• Microfracture treatment

Conditions studied

• Cartilage Injury — all drugs for Cartilage Injury →
• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Medipost Co Ltd. — full company profile →

Who can join

18 and older, any sex, with Cartilage Injury or Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• ICRS Cartilage Repair Assessment will follow to determine the appropriate grade. The treatment will be considered efficacious if the ICRS grade drops by at least 1 grade or more from baseline to week 48.
  Time frame: Week 0 and 48

Sponsor's own description

The purpose of the study is to assess and compare the safety and efficacy of the allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product (Cartistem®) to that of a microfracture treatment in patients with articular cartilage defect or injury.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Brief Overview of Global Trends in MSC-Based Cell Therapy.
   Jovic D, Yu Y, Wang D, Wang K, et al · · 2022 · cited 186× · PMID 35344199 · DOI 10.1007/s12015-022-10369-1
2. Adult Stem Cells for Bone Regeneration and Repair.
   Iaquinta MR, Mazzoni E, Bononi I, Rotondo JC, et al · · 2019 · cited 176× · PMID 31799249 · DOI 10.3389/fcell.2019.00268
3. Mesenchymal stem/stromal cells as a valuable source for the treatment of immune-mediated disorders.
   Markov A, Thangavelu L, Aravindhan S, Zekiy AO, et al · · 2021 · cited 174× · PMID 33736695 · DOI 10.1186/s13287-021-02265-1
4. The use of mesenchymal stem cells for cartilage repair and regeneration: a systematic review.
   Goldberg A, Mitchell K, Soans J, Kim L, et al · · 2017 · cited 159× · PMID 28279182 · DOI 10.1186/s13018-017-0534-y
5. Allogeneic cell therapy bioprocess economics and optimization: single-use cell expansion technologies.
   Simaria AS, Hassan S, Varadaraju H, Rowley J, et al · · 2014 · cited 107× · PMID 23893544 · DOI 10.1002/bit.25008
6. Current perspectives in stem cell research for knee cartilage repair.
   Orth P, Rey-Rico A, Venkatesan JK, Madry H, et al · · 2014 · cited 80× · PMID 24520197 · DOI 10.2147/sccaa.s42880
7. Trends in clinical trials for articular cartilage repair by cell therapy.
   Negoro T, Takagaki Y, Okura H, Matsuyama A. · · 2018 · cited 71× · PMID 30345076 · DOI 10.1038/s41536-018-0055-2
8. The role and potential of umbilical cord blood in an era of new therapies: a review.
   Roura S, Pujal JM, Gálvez-Montón C, Bayes-Genis A. · · 2015 · cited 68× · PMID 26133757 · DOI 10.1186/s13287-015-0113-2