XSTEM-OA / Xintela - LARVOL DELTA

A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: Xindu Pty Ltd | N=54 ➔ 24

Enrollment change • Immunology • Osteoarthritis • Pain • Rheumatology

A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=54 | Active, not recruiting | Sponsor: Xindu Pty Ltd | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=54 | Active, not recruiting | Sponsor: Xindu Pty Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

Xintela completes XSTEM dosing at third and final dose level in knee osteoarthritis clinical study (Market Screener) - "All patients on the third and final dose level have now been dosed in Xintela’s first-in-human study (Phase I/IIa) for the treatment of knee osteoarthritis in Australia where three different dose levels of the stem cell product XSTEM® are being tested. The primary goal of the study is to show that XSTEM is safe but also to investigate preliminary efficacy signals."

Trial status • CNS Disorders • Osteoarthritis • Pain

Xintela has started last dose level of XSTEM in knee osteoarthritis clinical study (Market Screener) - "Xintela’s first-in-human study (Phase I/IIa) for the treatment of knee osteoarthritis, being conducted in Australia, is testing three different dose levels of the stem cell product XSTEM®. The Safety Review Committee for the clinical study assessed the treatment of the eight patients on the second dose level with XSTEM at the one-month follow-up, concluded the dose is safe, and approved the continuation to dosing of patients at the third and last dose level. XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is developed and manufactured by Xintela....Safety data from all dose levels and early efficacy results are expected in 2023."

P1/2 data • Trial status • CNS Disorders • Osteoarthritis • Pain

A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: Xindu Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology

A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=54 | Not yet recruiting | Sponsor: Xindu Pty Ltd

New P1/2 trial • Immunology • Osteoarthritis • Pain • Rheumatology