17.06.2026

Ongoing research domains - Cell therapies

Founded in 2006, the Swiss Stem Cell Foundation (SSCF) has established itself as a cornerstone in the field of non-profit scientific research, driven by a clear mission: to bridge the gap between laboratory discoveries and real-world medical applications. For nearly two decades, the Foundation has dedicated its efforts to applied and clinical research, striving to develop innovative methods that directly improve patient care.

The year 2025 marked a significant turning point in the Foundation's history, characterized by a major strategic reorganization aimed at strengthening this mission. This evolution was spearheaded by the appointment of a new CEO and the inclusion of a dedicated Regulatory Affairs Specialist within the core team. These key leadership changes have injected a renewed energy into the SSCF, fostering a dynamic environment focused on concrete results. This fresh executive structure has provided the necessary impulse to further evolve the Foundation’s approach to funding and grant submissions. This strategic capability had already been robustly established following the arrival of a specialized Postdoctoral researcher in 2024, whose expertise laid the groundwork for high-level scientific writing.

The new Regenerative Medicine Institute of Lugano

The new SSCF Institute of Regenerative Medicine is a cutting-edge applied research center focusing primarily on stem cell-based therapies. The building is in the hospital district of Lugano and serves as a hub for the development of applied research and training in the field of stem cells, which is one of the SSCF's key activities.

The applied research laboratory within the institute aims to make it the centerpiece of a global vision in biomedicine, where researchers, doctors and engineers can develop projects in the field of stem cells.

The new institute is spread over four floors, covering a total of 3,500 square meters. The first floor houses the laboratories and clean rooms to produce regenerative medicine treatments and the new cryobank. The second level houses the SSCF's research laboratories and offices. The third level is dedicated to biotechnology start-ups, and the fourth level houses medical offices and clinics for the direct application of treatments.

The facility is completed by two 50-seat meeting rooms and a 100-seat conference room with a view of the city of Lugano.

Grant writing: the eligibility to Swiss National Science Foundation and to Innosuisse

2025 marked a significant milestone in SSCF’s grant writing endeavors. Our researchers successfully secured accreditation from the Swiss National Science Foundation (SNSF) and Innosuisse as research partners. This recognition will enable the full financial support of its project by both entities. The findings from this project will significantly enhance the foundation’s research activities, facilitating the collection of data for the development of new processes and products.

Furthermore, the Helvetic Confederation has signed an agreement with the European Union, granting Swiss entities the opportunity to participate in the Horizon project proposal. Lastly, SSCF is actively engaged in discussions with private corporations to secure the provision of validation services and GMP consulting. SSCF welcomes new collaborations to finalize the submission of grant proposals. This initiative aims to enhance scientific research in the field of regenerative medicine.

A list of the project presented during 2025:

1. CD38 studies (SNSF)

Starting Grant (January 2025), Bridge Proof of concept (March 2025). Those projects investigate the behavior of CD38 in adipose-derived stem cells (ASCs) under varying temperatures, with the objective of comprehending how cells endure freezing and preserve their regenerative capabilities. The ultimate aim is to pinpoint the pathways that facilitate cell survival and functionality post-cryopreservation.

2. SUST-STAM (Interreg – June 2025)

This 30-month project aims to establish a cross-border ecosystem for stem cell-based regenerative medicine. It supports startups and involves researchers, clinicians, and businesses to foster local innovation and achieve GMP-compliant results. The project provides access to labs, bioreactors, clean rooms, shared spaces, validation support, and guidance on business models and investments. Additionally, the network promotes shared infrastructure, stable cooperation, and advanced staff training.

The project envisions a network comprising SSCF (Switzerland), SUPSI (Switzerland), EOC (Switzerland), Università degli Studi dell’Insubria (Italy), Università del Piemonte Orientale (Italy), Fondazione Istituto Insubrico di Ricerca per la Vita – FIIRV (Italy), and HETA RES SRL (Italy). Decision about financing will be made by end of 2025.

3. Amniotic membrane studies (SNSF Bridge Proof of Concept – June 2025)

This project seeks to develop a standardized, cell-free therapeutic product derived from human amniotic membrane, specifically for chronic wound care and ocular surface regeneration. By employing an innovative stabilization process and automated tissue preparation, the product maintains the membrane’s inherent regenerative properties while ensuring consistency, scalability, and the ability to be stored at room temperature.

4. AutoMATeD (Horizon – September 2025)

This Horizon project, spearheaded by P.B.L. SRL, an Italian company that developed the device at the heart of the project, aims to fully automate the GMP preparation process. Although the device, an automated isolator, represents a significant investment, it is considered a long-term strategic project. Its high level of automation will minimize manual labor, and SSCF could install the system in their new Regenerative Medicine Institute in Lugano.

The project envisions a collaborative network involving SSCF (Switzerland), P.B.L. SRL (Italy), Hemera Srl (Italy), Établissement Français du Sang (France), and Istituto Romagnolo per lo Studio dei Tumori Dino Amadori – IRST S.r.l. (Italy). Decision about financing will be in the first trimester of 2026.

5. The Dual Role of Peripheral Prostate Adipose Tissue (PPAT) in Urological Malignancies

Johnson & Johnson Foundation (Oct 2025); Swiss Cancer Research (Dec 2025). The foundation’s objective is to establish a novel therapeutic platform that enhances the treatment of prostate and bladder cancer, two prevalent and clinically intricate urological malignancies. The methodology employs cells derived from PPAT as biologically active carriers for anticancer drugs, thereby transforming previously inert adipose tissue into an active therapeutic agent.

6. AcTivita (Innosuisse – November 2025)

The project’s objective is to minimize costs and production time by developing a closedloop platform for GMP-compliant CAR T cell manufacturing. In this process, a patient’s leukapheresis bag is connected to the AcTivita platform, which facilitates cell growth, CAR insertion, and quality assessment. Subsequently, a second bag collects the ready to-use CAR-T cells for the patient. The project envisions a network comprising SSCF, SUPSI, SSCB, and AxCellerate Sagl. Information about the results will be disclosed by the end of the year.

Corporate and Contract Development and Manufacturing Organization

SSCF also offers CDMO services and is open to collaboration with private companies. The SSCF is specifically equipped to provide comprehensive services related to the validation and design of new drug products and Advanced Therapy Medicinal Products (ATMPs).

Our core capabilities in validation ensure that all processes and products meet stringent regulatory and quality standards. Our design expertise focuses on establishing efficient and robust development pathways for these complex and innovative therapies. Furthermore, the SSCF provides expert consultation on related subjects, leveraging deep industry knowledge to support partners and clients through strategic guidance, technical problem-solving, and efficient project execution across the entire development lifecycle.

Below are two actual examples of the collaboration SSCF was able to establish.

1. Stem Sel® (Corporate – 2024 / 2025)

The STEMSEL project, starting January 2026 and lasting for 18 months, centers on the utilization of Celector, a microfluidics-based device engineered for label-free cell separation, live cell imaging, and cell collection. The system effectively separates cells based on their physical attributes, including size, shape, and density, while maintaining their physiological state and regenerative potential, owing to the absence of immunolabeling.

The role of the Foundation will be to upgrade the Stemsel protocol to a GMP lever in order to deliver cells directly to patients from a controlled medical environment. Following the successful biological validation completed in 2023, which demonstrated the device’s ability to effectively separate cells without manipulating them, the collaboration between Stem Sel® S.r.l. and the Swiss Stem Cell Foundation is now advancing toward its most critical milestone: clinical translation.

We have officially received the mandate to execute the comprehensive Good Manufacturing Practice (GMP) validation of the Celector® device, a rigorous process scheduled to span from January 2026 to June 2027.

This new phase marks the transition of the technology from a purely experimental tool into a medical-grade instrument capable of producing safe, high-quality cells for human therapy.

While the initial research focused on stem cells derived from adipose tissue (the Stromal Vascular Fraction), this upgrading program has been significantly expanded to also include the validation of cells extracted from the placenta. This addition represents a crucial development, as it widens the potential therapeutic applications of the device.

Over the course of these eighteen months, our team will work to establish strict sterility protocols and simulate the entire separation process within our certified clean rooms.The ultimate goal is to demonstrate to the regulatory body, Swissmedic, that the device can isolate these fragile cells based solely on their physical properties, preserving their natural regenerative potential while guaranteeing the absolute safety and sterility required for patient treatment.

2. White Nest (Corporate – 2025)

The project aims to produce allogeneic platelet-rich plasma (PRP) from batches of human cord blood. The industrial partner is an Italian company (White Nest) and the project should start at the beginning of 2026. A non-GMP protocol transfer is planned from a Spanish company to our Foundation in the next 6 months of 2026. This will not be afully industrial upgrade but already represents a scale-up level and the Foundation will develop all the GMP protocols allowing this scale-up.

Congress and Events participation

Over the past year, SSCF has significantly strengthened its footprint within the Swiss scientific landscape through an intensified program of participation in key congresses and industry symposia. A cornerstone of this strategic expansion has been the formalization of our membership with the Swiss MedTech Association.

During the autumn and winter of 2025, SSCF actively contributed to the scientific discourse through the dissemination of our latest research findings, utilizing both poster sessions and oral presentations to show case data on stem cell cryopreservation and regulatory advancements :

Lac Leman Regenerative Medicine Symposium

«Adipose Derived Stem Cells resist better to cryopreservation than whole stromal vascular cells: Highlighting CD38 implication.»

Roundtable: «Trends and Critical Issues in the MedTech Regulatory Sector»

Lugano, September 2025. Participated in a high-level discussion organized by the Swiss MedTech Ticino chapter, focusing on the evolving regulatory landscape.

National Regulatory Conference 2025

Bern, October 2025. Attended the flagship regulatory event organized by Swiss MedTech, ensuring alignment with national, European and international compliance standards.

Regenerative Medicine Day 2025

Genolier, November 2025. Represented the Foundation at the specialized gathering hosted by Swiss Medical Network.

The STEM-Restore T dossier

In the context of the regulatory pathway for the STEM-Restore T Dossier, the Foundation has dedicated significant resources to meticulously address the inquiries raised by Swissmedic regarding the market authorization of this new Advanced Therapy Medicinal Product (ATMP). To fully align with the authority’s stringent requirements, we successfully coordinated and executed a comprehensive validation campaign.

This effort included the drafting of new protocols and the execution of extensive process validations to demonstrate manufacturing consistency, as well as rigorous analytical method validations to ensure the robustness of our testing procedures. Having incorporated the resulting data into a formal response package, we have submitted the necessary amendments and are currently awaiting Swissmedic's official feedback regarding the evaluation of these corrective measures. The above-described tests are intended as one step forward the complete authorization of the ATMP, that was fully developed by SSCF.

Tommaso Tramonte and Dr. Luca Mariotta

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Ongoing research domains - Cell therapies

The new Regenerative Medicine Institute of Lugano

Grant writing: the eligibility to Swiss National Science Foundation and to Innosuisse

A list of the project presented during 2025:

1. CD38 studies (SNSF)

2. SUST-STAM (Interreg – June 2025)

3. Amniotic membrane studies (SNSF Bridge Proof of Concept – June 2025)

4. AutoMATeD (Horizon – September 2025)

5. The Dual Role of Peripheral Prostate Adipose Tissue (PPAT) in Urological Malignancies

6. AcTivita (Innosuisse – November 2025)

Corporate and Contract Development and Manufacturing Organization

Congress and Events participation

Lac Leman Regenerative Medicine Symposium

Roundtable: «Trends and Critical Issues in the MedTech Regulatory Sector»

National Regulatory Conference 2025

Regenerative Medicine Day 2025

Swiss Medical Network publishes the Science & Innovation Report 2025 and the Science & Innovation newsletter, Spring 2026 edition

Cell therapies - Main Research and Development Activities Conducted in 2025