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Randomized, Prospective, Double Blind, Multi-Center, Phase 3 Pivotal Clinical Trial to Compare Efficacy and Safety of CARTISTEM® and Surgical Comparator in Subjects With Knee Cartilage Lesions and Osteoarthritis

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Trial Profile

Randomized, Prospective, Double Blind, Multi-Center, Phase 3 Pivotal Clinical Trial to Compare Efficacy and Safety of CARTISTEM® and Surgical Comparator in Subjects With Knee Cartilage Lesions and Osteoarthritis

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Feb 2026

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At a glance

  • Drugs SMUP-IA-01 (Primary)
  • Indications Osteoarthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms CARTISTEM23-01
  • Sponsors Medipost

Most Recent Events

  • 17 Feb 2026 Planned number of patients changed from 1200 to 300.
  • 13 Feb 2026 According to Medipost media release, patient enrollment is expected to begin in the first half of 2026.
  • 13 Feb 2026 According to Medipost media release, the company announced that it has filed an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) to support the initiation of a Phase III clinical trial evaluating its investigational cell therapy for knee osteoarthritis.

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