Xintela publishes safety and efficacy results from knee osteoarthritis clinical study with XSTEM in scientific journal
The positive results from Xintela’s (XINT) clinical study (Phase I/IIa) on XSTEM for knee osteoarthritis have now been published in the peer-reviewed scientific journal Cartilage. The results show in addition to safety that the XSTEM treatment reduced knee pain, improved joint function and improved cartilage and bone tissue, supporting a disease-modifying effect of XSTEM.
The results of Xintela’s first-in-human (Phase I/IIa) clinical study with XSTEM for the treatment of knee osteoarthritis, which were reported in September 2025, have now been reviewed and published in the scientific journal Cartilage. In the study, three dose levels (4, 8 and 16 million stem cells) of Xintela’s stem cell product XSTEM, consisting of integrin α10β1-selected mesenchymal stem cells (MSCs), were evaluated in 24 patients (8 patients/dose level) with symptomatic moderate knee osteoarthritis.
In the publication, safety and tolerability of XSTEM are shown at all dose levels, with no serious adverse events related to the treatment. Further, the efficacy results demonstrate statistically significant and clinically meaningful improvements in knee pain and knee function. The highest dose also improved bone structure and cartilage tissue quality up to two years after treatment and showed a trend of stopping cartilage breakdown. The results support a disease-modifying effect of XSTEM.
The publication discusses among other things that the XSTEM results compare favourably with previously published results from studies using conventional (non-selected) MSCs and highlights the advantages of integrin α10β1-selected MSCs.
Comment from Xintela’s Chief Scientific Officer, Lucienne Vonk:
“The publication of the results from our knee osteoarthritis study, in a top tier peer-reviewed scientific journal, represents an important external validation of our study. Additionally, it ensures that our results are now available for potential partners and other stakeholders. Our exciting results that XSTEM shows disease modifying effects and that patients experience symptom relief up to at least two years after a single injection, offers great promise to the millions of osteoarthritis patients who are seriously affected by pain and immobility.”
For further information contact Lucienne.vonk@xintela.se
About osteoarthritis
Osteoarthritis is a chronic, progressive, degenerative joint disease and a leading cause of pain and immobility in adults, and significantly impacts quality of life. Globally, over 595 million people suffer from osteoarthritis1. Current treatments rely mostly on pain management as there is no disease-modifying treatment available. MSCs have emerged increasing interest as an effective treatment for osteoarthritis due to their regenerative, anti-inflammatory and immunomodulatory properties.
About XSTEM
XSTEM is a proprietary, best-in-class stem cell product consisting of integrin α10β1-selected MSCs from donated adipose tissue. Xintela’s selection technology quality assures homogeneity, potency and consistency of the allogeneic MSCs and gives XSTEM a functional and regulatory advantage compared to other MSC-based therapies using non-selected, heterogenous MSC preparations.
The publication:
Safety and Efficacy of Allogeneic Integrin α10β1-Selected Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis: A First-In-Human Phase I/IIa Dose Escalation Study. Lucienne A. Vonk, Camilla Wennersten, Kristina Uvebrant, Kavitha Siva, Liselotte Theorell, Marc Russo, Stephen Hall, and Evy Lundgren-Åkerlund. Cartilage. 2026. Doi: 10.1177/19476035261475741
Link to the publication: https://journals.sagepub.com/doi/epub/10.1177/19476035261475741
Reference: 1 GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990–2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023;5:e508-22
Contacts
Xintela AB (publ)
Evy Lundgren-Åkerlund, CEO
Tel: +46 46 275 65 00
Email: evy@xintela.se
Medicon Village
223 81 Lund, Sweden
www.xintela.se
About Xintela
Xintela (XINT) is a publicly-traded clinical-stage biopharma company developing cutting edge medical products in stem cell therapy and targeted cancer therapy. Xintela’s proprietary technology uses the stem cell marker integrin α10β1 to select and quality-assure stem cells in the product XSTEM®, which has shown safety and positive efficacy in a clinical study on knee osteoarthritis and has completed a clinical study on difficult-to-heal leg ulcers. Xintela’s in-house GMP-facility manufactures XSTEM and provides process development and manufacturing of other cell therapies. Xintela’s wholly owned subsidiary Targinta AB develops First-in-Class therapeutic antibodies targeting integrin α10β1. TARG9, an Antibody-Drug Conjugate (ADC), and TARG10, a function blocking antibody, are in preclinical development for the treatment of aggressive, difficult-to-treat cancers including glioblastoma, triple-negative breast cancer and sarcoma. Xintela conducts its business at Medicon Village in Lund, Sweden, and is listed on Nasdaq First North Growth Market Stockholm. Xintela's Certified Adviser is Tapper Partners AB.