Autoimmune disease is more than “inflammation.” It is a form of biological friendly fire: the immune system mistakes the body’s own tissues for a threat and begins to attack them. In psoriasis the target is often the skin. In rheumatoid arthritis it is the joint environment. In type 1 diabetes it is the insulin-producing beta cell. In Crohn’s disease the digestive tract becomes a chronic battleground. For patients, the result can be visible flares, pain, fatigue, organ damage, social isolation, loss of work capacity, and long periods of uncertainty. This burden helps explain why cell therapy now attracts so much attention [1,2].

Conventional drug therapy has transformed autoimmune care, and it should never be dismissed. Biologics, immune-modulating drugs, and targeted anti-inflammatory agents can be life-changing. Yet many patients still do not reach the outcome they actually want: durable remission without rapid relapse, progressive disability, or lifelong escalation of treatment. In real-world conversation, people often call the hoped-for endpoint a “cure.” In scientific writing, the safer terms are deeper remission, drug-free remission, preserved organ function, or, in type 1 diabetes, insulin independence. That difference in language matters because it protects both patients and science from exaggerated promises.

Conventional drugs usually work by suppressing specific inflammatory pathways while treatment continues. Cell therapy aims at something potentially deeper. Mesenchymal stromal-cell approaches are investigated because they can release anti-inflammatory signals, promote regulatory immune states, and support damaged tissue environments. Hematopoietic stem-cell transplantation, in carefully selected severe disease, may go even further by attempting an immune “reset” [1,2]. That does not mean every autoimmune disease is ready for the same approach, or that every patient should receive cell therapy. It does mean the therapeutic ambition is different: not only to dampen the fire, but to change the rules that keep reigniting it.

The evidence base is no longer theoretical. In recent-onset type 1 diabetes, a simplified autologous hematopoietic stem-cell transplant study reported an 81% overall response, with insulin independence in 7 of 16 patients and zero 100-day mortality in that series [3]. In another type 1 diabetes line of research, a randomized placebo-controlled trial of umbilical-cord-derived mesenchymal stromal cells suggested safety and preservation of endogenous insulin production [4]. In psoriasis, a phase 1/2a study of human umbilical-cord mesenchymal stem cells showed a favourable safety profile and clinically meaningful responses in a proportion of patients [5]. In rheumatoid arthritis, both a phase Ia trial and a later systematic review/meta-analysis support a favourable safety signal and a trend toward clinical benefit, although larger and more definitive trials are still needed [6,7]. In Crohn’s disease, a 2024 meta-analysis found that stem-cell therapy improved the chance of clinical remission in difficult disease settings [8].

Cell therapy is promising, but it is not exempt from failure. A useful cautionary example is darvadstrocel (Alofisel), a cell therapy once authorised in Europe for complex perianal fistulas in Crohn’s disease. In 2024 it was withdrawn from the EU market after confirmatory evidence failed to secure its benefit profile [9]. That episode is not an argument against cell therapy. It is an argument for better evidence, honest endpoints, and rigorous follow-through. Patients deserve access, but they also deserve therapies that survive real scrutiny.

When autoimmune disease becomes severe, the consequences are not abstract. A person with rheumatoid arthritis may lose hand function, work ability, and independence. A person with type 1 diabetes may live for decades with insulin dependence, glucose monitoring, and fear of severe metabolic events. A person with Crohn’s disease may face pain, fistulas, repeated procedures, and chronic fatigue. A person with psoriasis may carry not only inflammation but also stigma. That is why some patients begin to look beyond their own country. Publicly visible providers such as CellCenter Slovakia present themselves as regenerative-medicine centres and state that treatment is carried out in cooperation with Malacky Hospital [15,16]. Poland, meanwhile, has a formally described ATMP-Hospital-Exemption framework [13]. But the same Polish literature also warns that weak oversight can allow unproven cell interventions to proliferate [14]. The lesson is simple: patients need access and protection together, not one without the other.

The Hospital Exemption pathway is not a legal loophole for anything a clinic wants to sell. Under EU law, it applies to advanced therapy medicinal products prepared on a non-routine basis, under specific quality standards, for use within the same Member State, in a hospital, under the exclusive professional responsibility of a medical practitioner, and for an individual patient [10]. A 2025 EU study found that Member States have implemented this framework differently, which helps explain why access across Europe feels patchy and inconsistent [11]. Position papers from the European field argue that Hospital Exemption should be preserved as an essential access route, while also strengthening harmonisation, reporting, and accountability [12].

For DEPCELL, the challenge is not only technical. Better cell-selection technology matters, but so does the policy environment in which therapies are evaluated and delivered. Europe already allows advanced therapies, including ATMP-Hospital-Exemption use, but national implementation can still be slowed by fragmented rules, unfamiliarity, or institutional fear of new categories of treatment [10-13]. At the same time, the EMA has warned that unregulated advanced-therapy products pose serious risks to patients [17]. So the real public-policy choice is not between total freedom and total prohibition. It is between bad regulation and good regulation.

Smarter access would mean risk-based rules, proportionate requirements for different levels of clinical complexity, strong traceability, pharmacovigilance, transparent outcome reporting, and commercially realistic pathways for selected diseases. It would mean enough control to exclude unsafe or exploitative practice, but enough practical flexibility that lawful, evidence-building cell therapies can actually reach patients before disability becomes permanent. In that sense, the debate is not only scientific. It is ethical and economic. A system that is too loose can harm people with false hope. A system that is too rigid can push desperate patients into medical tourism or leave them trapped in long cycles of incomplete control.

The argument for broader cell-therapy access in autoimmune disease should therefore be made carefully but clearly. These therapies are not magic. They will not work equally for every disease, every stage, or every patient. But the field has already advanced beyond speculation. Europe has lawful mechanisms, clinical precedents, and enough evidence to justify serious, structured implementation work [1-13]. The next step is not hype. It is maturity: better data, better manufacturing, better selection of cells, better patient selection, and better national policy. That is the space in which DEPCELL’s technology work and policy work can meet. The goal is simple to state even if it is hard to build: fewer years lost to uncontrolled autoimmunity, fewer patients pushed into avoidable disability, and a more intelligent regenerative-medicine framework for the future.

Selected references:

1. Alexander T, Sharrack B, Rovira M, Saccardi R, Farge D, Snowden JA, Greco R. Autoimmune Disease. In: Sureda A, Corbacioglu S, Greco R, et al., editors. The EBMT Handbook: Hematopoietic Cell Transplantation and Cellular Therapies. 8th ed. Cham: Springer; 2024. doi:10.1007/978-3-031-44080-9_92.
2. European Society for Blood and Marrow Transplantation (EBMT). Scientific report 2024 of the Autoimmune Diseases Working Party (ADWP). Available from: https://www.ebmt.org/annual-report-2024/scientific-report-2024-autoimmune-diseases-working-party-adwp (accessed 2026-04-06).
3. Cantu-Rodriguez OG, Lavalle-Gonzalez F, Herrera-Rojas MA, Jaime-Perez JC, Hawing-Zarate JA, Gutierrez-Aguirre CH, et al. Long-Term Insulin Independence in Type 1 Diabetes Mellitus Using a Simplified Autologous Stem Cell Transplant. J Clin Endocrinol Metab. 2016;101(5):2141-2148. doi:10.1210/jc.2015-2776.
4. Carlsson P-O, et al. Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial. Diabetologia. 2023;66(8):1431-1441. doi:10.1007/s00125-023-05934-3.
5. Cheng L, Wang S, Peng C, et al. Human umbilical cord mesenchymal stem cells for psoriasis: a phase 1/2a, single-arm study. Signal Transduct Target Ther. 2022;7(1):263. doi:10.1038/s41392-022-01059-y.
6. Mesa LE, Lopez JG, Lopez-Quiceno LG, Barrios Arroyave F, Halpert K, Camacho JC. Safety and efficacy of mesenchymal stem cells therapy in the treatment of rheumatoid arthritis disease: A systematic review and meta-analysis of clinical trials. PLoS One. 2023;18(7):e0284828. doi:10.1371/journal.pone.0284828.
7. Park EH, Lim HS, Lee S, Roh K, Seo KW, Kang KS, Shin K. Intravenous Infusion of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in Rheumatoid Arthritis: A Phase Ia Clinical Trial. Stem Cells Transl Med. 2018;7(9):636-642. doi:10.1002/sctm.18-0031.
8. Qiu Y, Li C, Sheng S. Efficacy and safety of stem cell therapy for Crohn’s disease: a meta-analysis of randomized controlled trials. Stem Cell Res Ther. 2024;15(1):28. doi:10.1186/s13287-024-03637-z.
9. European Medicines Agency. Alofisel withdrawn from the EU market. 2024 Dec 13. Available from: https://www.ema.europa.eu/en/news/alofisel-withdrawn-eu-market (accessed 2026-04-06).
10. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products. Available from: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF (accessed 2026-04-06).
11. Publications Office of the European Union. Study on the hospital exemption. 2025. Available from: https://op.europa.eu/publication/manifestation_identifier/PUB_HW0125012ENN (accessed 2026-04-06).
12. Sanchez-Guijo F, Avendano-Sola C, Badimon L, et al. Role of Hospital Exemption in Europe: position paper from the Spanish Advanced Therapy Network (TERAV). Bone Marrow Transplant. 2023;58(6):727-728. doi:10.1038/s41409-023-01962-0.
13. Pachocki J, Verter F. Polish regulatory system regarding ATMP hospital exemptions. Front Immunol. 2024;15:1379134. doi:10.3389/fimmu.2024.1379134.
14. Dulak J, Pecyna M. Unproven cell interventions in Poland and the exploitation of European Union law on advanced therapy medicinal products. Stem Cell Reports. 2023;18(8):1610-1620. doi:10.1016/j.stemcr.2023.05.017.
15. CellCenter Slovakia. About us. Available from: https://www.cellcenterslovakia.com/en/about-us/ (accessed 2026-04-06).
16. CellCenter Slovakia. FAQ: Where is the patient’s treatment carried out? Available from: https://www.cellcenterslovakia.com/en/faq-2/ (accessed 2026-04-06).
17. European Medicines Agency. Unregulated advanced therapy medicinal products pose serious risks to health. 2025 Mar 13. Available from: https://www.ema.europa.eu/en/news/unregulated-advanced-therapy-medicinal-products-pose-serious-risks-health (accessed 2026-04-06).