2024-05-03
46 Swedish clinical trials reported in ATMP since 2006, 26 since 2021....
ATMP centers have been established at four of the seven university hospitals in Sweden, yet all the hospitals have activity within ATMPs. To provide more insight into the activity at the different university hospitals the national network for ATMP centra have put together a list of the clinical ATMP trials at the university hospitals. This list has now been published on the on the ATMP Center’s National collaboration webpage and will be updated quarterly.
What have we learned from this initial list? 45 ATMP based clinical trials have been identified from Swedish University Hospitals, 25 for Uppsala, 14 for Skåne, 9 for Sahlgrenska (Gothenburg), 7 for Karolinska, 2 for Umeå and 1 for Örebro. While Uppsala University Hospital has been a dominant figure, since 2021 the numbers are starting on a new trend. Running their first ATMP trial in 2021, Sahlgrenska University Hospital now has 9 trials under their belt, on par with Uppsala University Hospital for the same time period. Skåne University Hospital however has 13 ATMP trials during this period. Currently open (recruiting or in follow-up) clinical trials include 14 from Uppsala, 13 from Skåne, 9 from Karolinska, 5 from Sahlgrenska and 1 each for Örebro and Umeå.
The first ’ATMP’ clinical trial on the list in Sweden was a gene therapy for urinary bladder carcinoma in 2006 (the ATMP legislation did not come in until 2007). Between 2006 and 2017 only Uppsala University Hospital was found to be running ATMP trials, racking up 10 before Skåne University Hospital and Karolinska University Hospital joined the list in 2018 with YESCARTA and BREYANZI CAR T trials. In 2020 Örebro University Hospital joined the list with the NextCell Pharma ProTrans trial for Acute Respiratory Distress Syndrome associated with COVID19. Umeå stormed in 2021 with their CRISPR Cas9 trial, sponsored by Intellia Therapeutics, making them one of few in the world to treat patients with such a modality. In 2021 Sahlgrenska University Hospital joins the list with Kymriah for pediatric patients.
Many modalities are included in the list, adenoviral vector gene therapy (2006), DNA vaccine (2008), dendritic cells (2011), CAR T (2014), RNA (2016), oncolytic adenovirus (2016), mesenchymal stromal cells (2017), AAV gene therapy (2019), CRISPR Cas9 (2021), recombinant bacteria GTMP (2022), pluripotent derived dopaminergic progenitors (2023) and finally hypoimmune pancreatic islet transplant (2024). Indications addressed favour oncology though Diabetes, hemophilia, foot ulcer, Duschenne Muscular Dystrophy, limb ischemia, Parkinson Disease and Skellefteåsjukan are also represented.
It is clear that ATMP clinical trials are growing rapidly in Sweden. Running an ATMP clinical trial often entails a lot of logistics and requires good collaboration between several different units at the hospital, e.g. apheresis unit, stem cell lab, pharmacy, clinical trials unit etc. The Swedish Hospital ATMP centers were established to share information and experience with the different units at the hospital and between each other to support one another and learn from previous experience. Many of the ATMP centers work closely with the clinical trials units at the hospital and support feasibility requests and start-up processes for clinical trials with ATMPs. This list will be an additional tool to support collaboration and knowledge-sharing.
Keep in mind that an important aspect of this list is the CTIS (or EudraCT) number which indicates that the trial has applied for approval from the MPA and makes it possible for interested parties to look up more information about the trial in EMA’s registries. The NCT number is for studies that are registered by the trial sponsor on clinicaltrials.gov. The hospital ATMP Centers will also work to make sure sponsors have the best support possible to know how to govern their ATMP trials.
Although the ATMP centers have tried their best to make this an exhaustive list, it is almost certainly not complete. This national compilation is based on clinical trials reported to the ATMP centers. If your trial is missing, or one that you know of, please contact your local ATMP center!
Learn more about the hospital ATMP centers and find the clinical trials list on their National collaboration webpage!