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).

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2018-03-27
The Data and Safety Monitoring Board approves the usage of medium-dose ProTrans in the ongoing clinical trial.
Stem cell company NextCell Pharma AB ("NXTCL") announces today that the Data and Safety Monitoring Board for the clinical trial using ProTrans has given its approval for the principal investigator professor Per-Ola Carlsson and NextCell to proceed and treat 3 patients in the medium-dose cohort. The Data and Safety Monitoring Boards consists of; Ulf Smith MD, PhD, Professor and Director, Lundberg Laboratory for Diabetes Research, Sahlgrenska Academy and Sahlgrenska University Hospital, Gothenburg; Anders Fasth MD, PhD, Professor of Pediatric Immunology, Sahlgrenska Academy and Chief Physician
Stem cell company NextCell Pharma AB ("NXTCL") announces today that the Data and Safety Monitoring Board for the clinical trial using ProTrans has given its approval for the principal investigator professor Per-Ola Carlsson and NextCell to proceed and treat 3 patients in the medium-dose cohort. T...
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2018-03-14
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NextCell Pharma (NXTCL), traded at AktieTorget, announces that a collaboration with Nordic Tech House has been agreed upon where Nordic Tech House will invest in NXTCL and develop the digital presence of NXTCL and Cellaviva. The two-year agreement means that Nordic Tech House will be responsible ...
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2018-03-06
NextCell CEO invited speaker at the Swedish National ATMP Conference
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NextCell Pharma AB ("NXTCL") announces that its CEO, Mathias Svahn PhD has been invited to speak at the 1st Swedish National Advanced Therapy Medicinal Product Conference held in Lund on March 15th. The topic of the lecture will be ‘Mesenchymal Stem Cells in Clinical Trials for Treatment of Autoi...
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2018-02-22
Three patients now treated with NextCells ProTrans stem cells
NextCell Pharma AB ("NXTCL") announces that three type 1 diabetes patients have been treated with ProTrans in the ongoing clinical phase I/II trial. Thus, all patients in the low-dose-cohort have now undergone treatment. The trial performed with NXCTCL's patent-pending ProTrans, is divided into two parts, the first part being a doseescalation phase with 3 + 3 + 3 patients being treated with either a; low, medium or high dose of ProTrans. Now that all patients in the low-dose-cohort have been treated and after the 1-month follow-up is completed we can start inclusion of patients in the
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2018-02-16
NextCell Pharma files patent application
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2018-01-31
NextCell Pharma changes ticker to NXTCL
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2018-01-24
First diabetes patient treated with ProTrans stem cells
NextCell Pharma AB ("NextCell") announces that the first patient with type 1 diabetes has now been treated with the company's drug candidate ProTrans. The clinical trial evaluates the safety and efficacy of ProTrans after treatment of patients 18-40 years old and who had type 1 diabetes for a maximum of two years. The clinical trial started on November 28th, 2017 and after clinical assessment and baseline data collection, the first patient has now been treated (first-in-human) with ProTrans stem cells. The first part of the study is a three-step dose escalation with three patients in each
NextCell Pharma AB ("NextCell") announces that the first patient with type 1 diabetes has now been treated with the company's drug candidate ProTrans. The clinical trial evaluates the safety and efficacy of ProTrans after treatment of patients 18-40 years old and who had type 1 diabetes for a max...
Read moreRead more