Medical, Scientific, and Regulatory Updates
MIKS curates reliable and high-quality information published in the field of regenerative medicine, ensuring you can effortlessly stay current.
Certain news pieces are exclusively available to members. If you wish for unrestricted access to all news articles, you can achieve that by becoming a member of our community. Join as a member today to enjoy complete access to all our content.
01 diciembre 2025
CLINICAL RESEARCH
Use of injectable orthobiologics for the treatment of knee osteoarthritis. Part 2: injectable cell-based therapies
ESSKA ORBIT Consensus
The European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA) has recently published a formal consensus on the use of injectable cell-based therapies for knee osteoarthritis, as part of the ESSKA ORBIT project aimed at guiding evidence-based clinical practice.
The document, titled “Part 2 – Cell-based therapy” (doi: 10.1002/ksa.70001), examines the role of mesenchymal stem cells (MSCs) and other cell-based approaches, reviewing current evidence, patient selection criteria, administration protocols, safety, and follow-up.
Key findings from the consensus:
- Cell-based therapies show clinical potential in knee osteoarthritis but currently lack standardization and sufficiently robust evidence to be considered first-line treatment.
- Careful patient selection is essential, as well as defining the type of cellular product, dose, number of injections, and establishing clear follow-up protocols.
- Cell-based therapies should preferably be implemented within structured frameworks such as clinical trials or registries, ensuring clear patient information regarding benefits, risks, and expectations.
- Several knowledge gaps remain: lack of response biomarkers, need for mid- and long-term studies, and cost-effectiveness analyses.
- In Spain, these therapies fall under AEMPS regulation and are classified as Advanced Therapies. Their clinical use is only permitted in very specific and controlled contexts; routine application outside these settings is not authorized.
The ESSKA ORBIT consensus positions injectable cell-based therapies as a promising tool within orthobiology but emphasizes that they do not replace conventional treatments. Their use requires scientific rigor, standardized protocols, and participation in clinical studies or registries to generate solid evidence.
Reference:
European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA) – ORBIT Group. The use of injectable orthobiologics for knee osteoarthritis: A formal ESSKA ORBIT consensus. Part 2 — Cell based therapy. Knee Surg Sports Traumatol Arthrosc. 2025. doi: 10.1002/ksa.70001
Image gallery
