ProTrans and NextCell gain international attention

August 8, 2023

Results from Professor Per-Ola Carlsson, Principal Investigator for NextCell’s Phase-I/II study with ProTrans stromal cells for Type 1 Diabetes are now published and featured in the Up-front section of the current issue of Diabetologia. The article was selected by the Editor as worthy of special attention, for its high quality and interest to the diabetes field. Furthermore, the article has already been cited in an International scientific journal.

 “We are proud that our work is recognized and appreciated by the Editor. This will further increase the international exposure of NextCell”, says Mathias Svahn, CEO

Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD) summarizes the importance of the study on their website:

Umbilical cordderived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised doubleblind placebocontrolled trial
Per-Ola Carlsson, Daniel Espes, Sofia Sisay, Lindsay C. Davies, C. I. Edvard Smith and Mathias G. Svahn

Mesenchymal stromal cells (MSCs) have been shown to modulate the immune system and dampen inflammatory and autoimmune responses in numerous diseases. In this issue, Carlsson et al (https://doi.org/10.1007/s00125-023-05934-3) report their findings from a Phase I/II dose escalation and double-blind placebo-controlled clinical trial investigating the Wharton’s jelly MSC drug product, ProTrans, for the treatment of new-onset type 1 diabetes. In the dose escalation safety study, the authors demonstrate that ProTrans can be safely administered intravenously with no serious adverse events. A fixed dose of 200 million MSCs preserved the production of endogenous insulin and reduced exogenous insulin replacement compared with placebo 1 year after treatment. The authors conclude that a single treatment with ProTrans could potentially delay type 1 diabetes disease progression, thereby reducing the associated complications and improving quality of life.”

In the international scientific journal, Frontiers in Cell and Developmental Biology (June 2023), Hana Drobiova and coworkers list advantages of using stem or stromal cells from the umbilical cord, such as ProTrans, enabling the use of WJ-MSCs as therapeutic agents in regenerative medicine. In particular Professor Carlsson’s clinical trials using allogenic WJ-MSCs to investigate their safety and efficacy are highlighted

The clinical trial with ProTrans is a collaboration with Professor Per-Ola Carlsson, Principal Investigator at Uppsala University and Karolinska Trial Alliance, Karolinska University Hospital, Huddinge, Sweden (Clinicaltrials.gov identifier NCT03406585).

The article is available as open access at https://pubmed.ncbi.nlm.nih.gov/37221247/

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com

Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma


For more information about Cellaviva, please contact
Sofie Falk Jansson, Head of Cellaviva
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
Website:www.cellaviva.se


Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser, info@fnca.se.

About NextCell Pharma AB
NextCell is a cell therapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stromal cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to market approval for type-1 diabetes via a phase III study.  ProTrans is evaluated in two clinical COVID-19 studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5% of FamicordTX, a start-up company in CAR-T and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings of stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

Download attachmentRead full press release on Cision (external link)
2017-11-29
NextCell Pharma initiates stem cell trial for type 1-diabetes with ProTrans
NextCell Pharma AB ("NextCell") announces that the initiation meeting for the clinical trial in which drug candidate ProTrans will be evaluated, was held on November 28th, 2017. The trial will investigate safety as well as evaluate the patient’s own insulin production 12 months after receiving ProTrans stem cell treatment. Patients with type 1-diabetes being 18-40 years who received their diagnosis no later than 2 years ago and still have some insulin production are candidates for participation in the trial. NextCell Pharma has reached a new level as a company. I would like to thank all the
NextCell Pharma AB ("NextCell") announces that the initiation meeting for the clinical trial in which drug candidate ProTrans will be evaluated, was held on November 28th, 2017. The trial will investigate safety as well as evaluate the patient’s own insulin production 12 months after receiving Pr...
Read moreRead more
2017-11-14
Today Nextcell Pharma publishes its annual report 2016-2017
NextCell Pharma AB (publ) hereby publishes the annual report for the financial year 2016/2017. The annual report is attached to this press release and can be downloaded from the company's website www.nextcellpharma.com
NextCell Pharma AB (publ) hereby publishes the annual report for the financial year 2016/2017. The annual report is attached to this press release and can be downloaded from the company's website www.nextcellpharma.com...
Read moreRead more
2017-10-31
NextCell Pharma updates on its situation in its fourth quarter report
NextCell Pharma AB ("NEXTCL", "NextCell") today releases its Q4 / year-end report (June 1st - August 31st  / September 1st - August 31st). This is the first quarterly report since the listing on Aktietorget. The company reports a loss of SEK -4,757,996 in its fourth quarter and a loss of SEK -13,245,206 for the entire financial year. The remaining cash at August 31st was approximately 16 MSEK. The perhaps most important event during the fourth quarter was the listing on Aktietorget on July 13th and the associated listing issue, which was subscribed to approximately 18 MSEK, corresponding to
NextCell Pharma AB ("NEXTCL", "NextCell") today releases its Q4 / year-end report (June 1st - August 31st  / September 1st - August 31st). This is the first quarterly report since the listing on Aktietorget. The company reports a loss of SEK -4,757,996 in its fourth quarter and a loss of SEK -13,...
Read moreRead more
2017-10-17
NextCell Pharma's stem cell study in Type 1 Diabetes gets green light from the Medical Products Agency
NextCell Pharma AB ("NextCell") today announces that the Swedish Medical Products Agency has granted permission to conduct the clinical trial investigating the drug candidate ProTrans. For more information regarding the clinical trial, please see press release from 15th of September. This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the above contact person for publication on October 17th, 2017.
NextCell Pharma AB ("NextCell") today announces that the Swedish Medical Products Agency has granted permission to conduct the clinical trial investigating the drug candidate ProTrans. For more information regarding the clinical trial, please see press release from 15th of September. This inform...
Read moreRead more
2017-10-11
Family saving of stem cells at Underbara Barn held atStockholm International Fair and Congresses Centre,13-15 October, 2017
For the third consecutive year, Cellaviva will exhibit at the Underbara Barn Fair to meet and inform its (prospective) customers. The fair is targeted at future parents and those with young children. Representatives from the company will inform visitors about the family saving of stem cells from the umbilical cord. Cellaviva is Sweden's first and only biobank for family-saving of stem cells and is owned by the stem cell company NextCell Pharma AB (NEXTCL). The applications for stem cell therapy are rapidly growing in modern medicine. Cells from family members are preferred for the treatment
For the third consecutive year, Cellaviva will exhibit at the Underbara Barn Fair to meet and inform its (prospective) customers. The fair is targeted at future parents and those with young children. Representatives from the company will inform visitors about the family saving of stem cells from ...
Read moreRead more
2017-09-21
NextCell Pharma receives wholesale distribution authorisation
NextCell Pharma AB ("NextCell") today announces that the company has been granted license for wholesale of cell based investigational medicinal products. The company was inspected earlier this summer by the Swedish Medical Products Agency. The permission is required for NextCell to acquire, stock and distribute investigational drugs in the planned clinical trial of ProTrans™ for treatment of diabetes. CEO Mathias Svahn says “This license is a good next step towards the start of our first clinical trial with ProTrans™ for the treatment of patients with Type 1 diabetes”. About the clinical
NextCell Pharma AB ("NextCell") today announces that the company has been granted license for wholesale of cell based investigational medicinal products. The company was inspected earlier this summer by the Swedish Medical Products Agency. The permission is required for NextCell to acquire, stock...
Read moreRead more
2017-09-15
Update on NextCell Pharma’s clinical trial application
NextCell Pharma AB (NEXTCL) today announced that the company has responded to the Medicinal Product Agency's request for completion regarding the application for clinical trial with ProTrans ™. The study is designed to evaluate safety and efficacy in the treatment of type 1 diabetes. NextCell’s application was registered with the Medical Products Agency on July 24th and request for supplementary information was received on September 5th. This has now been submitted within the deadline of September 14th. The study is divided into two parts: The first part is a three-step dose escalation
NextCell Pharma AB (NEXTCL) today announced that the company has responded to the Medicinal Product Agency's request for completion regarding the application for clinical trial with ProTrans ™. The study is designed to evaluate safety and efficacy in the treatment of type 1 diabetes. NextCell’s a...
Read moreRead more
2017-09-05
NextCell Pharma AB receives approval from Ethics Committee for Clinical Trial
NextCell Pharma AB (NEXTCL) announced today that the clinical trial application for ProTrans™ has been granted by the Ehtics Committee. ProTrans™ is a stem cell product developed with NextCell's Proprietary Selection Algorithm. The clinical trial is designed to evaluate the safety and efficacy of ProTrans™ for treatment of patients with type 1 diabetes. The study sponsor is NextCell and the principal investigator is Professor Per-Ola Carlsson, who works at Uppsala University and the Academic Hospital in Uppsala. The study will be conducted together with Karolinska Trial Alliance (KTA), which
NextCell Pharma AB (NEXTCL) announced today that the clinical trial application for ProTrans™ has been granted by the Ehtics Committee. ProTrans™ is a stem cell product developed with NextCell's Proprietary Selection Algorithm. The clinical trial is designed to evaluate the safety and efficacy of...
Read moreRead more