NCT01626677

Long Term Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee

Completed Phase 3 Last updated 19 April 2017

What this trial tests

Phase 3 trial testing CARTISTEM in Degenerative Osteoarthritis in 103 participants. Completed in 1 May 2015.

Timeline

1 June 2012

Primary endpoint
1 May 2015

1 May 2015

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	103
Start date	1 June 2012
Primary completion	1 May 2015
Estimated completion	1 May 2015
Sites	10 locations across South Korea

Drugs / interventions tested

• CARTISTEM — full drug profile →
• Microfracture

Conditions studied

• Degenerative Osteoarthritis — all drugs for Degenerative Osteoarthritis →
• Defect of Articular Cartilage — all drugs for Defect of Articular Cartilage →

Sponsor

Medipost Co Ltd. — full company profile →

Who can join

18 and older, any sex, with Degenerative Osteoarthritis or Defect of Articular Cartilage. 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.

• Degree of improvement in knee assessments compared to the active control (microfracture)
  Time frame: 36 months, 48 months, and 60 months
  Knee assessments will be performed using the following tools: * IKDC (International Knee Documentation Committee) * Pain score on VAS (Visual Analogue Scale) * WOMAC (Western Ontario and McMaster Universities Arthritis Index)

Sponsor's own description

This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®, human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or defects, compared with microfracture. Subjects who participated in and completed the Phase III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.

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. Engineering Stem and Stromal Cell Therapies for Musculoskeletal Tissue Repair.
   Loebel C, Burdick JA. · · 2018 · cited 105× · PMID 29429944 · DOI 10.1016/j.stem.2018.01.014
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. Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cell Implantation Versus Microfracture for Large, Full-Thickness Cartilage Defects in Older Patients: A Multicenter Randomized Clinical Trial and Extended 5-Year Clinical Follow-up.
   Lim HC, Park YB, Ha CW, Cole BJ, et al · · 2021 · cited 64× · PMID 33490296 · DOI 10.1177/2325967120973052