A First-in-Human Open-Label Phase 1/2a Study to Evaluate Safety, Tolerability and Efficacy of a Single Intra-Articular Injection of Allogeneic Mesenchymal Stem Cells Selected for Integrin α10β1 (XSTEM-OA) in Adult Patients With Symptomatic Knee Osteoarthritis
Latest Information Update: 22 Apr 2025
At a glance
- Drugs Stem cell therapy-Xintela (Primary)
- Indications Musculoskeletal pain; Osteoarthritis
- Focus Adverse reactions; First in man
- Sponsors Xindu Pty Ltd
Most Recent Events
- 17 Apr 2025 Planned number of patients changed from 54 to 24.
- 28 Aug 2024 Time_frame for primary endpoint changed from 18 months to 24 months, exploratory endpoints added, hence the protocol was amended.
- 28 Aug 2024 Planned End Date changed from 1 Dec 2024 to 1 Jun 2025.