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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2018-12-05
NextCell strengthens the organization for continued growth
NextCell Pharma AB ("NextCell") hereby announces that the Board has decided to appoint Sofia Fredrikson to CFO in the company. Sofia Fredrikson will take office starting today. Former CFO, Leo Groenewegen, will continue to work for the company in the newly created role of Business Development Manager. Both Sofia Fredrikson and Leo Groenewegen will be part of NextCell's management team. Sofia Fredrikson, born 1983, has been employed by NextCell since November 2018. The Board has now decided to appoint Fredrikson as CFO for the company. Sofia Fredrikson has worked as an authorized accountant
NextCell Pharma AB ("NextCell") hereby announces that the Board has decided to appoint Sofia Fredrikson to CFO in the company. Sofia Fredrikson will take office starting today. Former CFO, Leo Groenewegen, will continue to work for the company in the newly created role of Business Development Man...
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2018-11-28
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NextCell Pharma AB ("NXTCL") announces that its CEO, Mathias Svahn PhD has been invited to speak at the Karolinska Institutet conference “From tissue to motion” - a 10-year anniversary. The conference brings together different research groups within the field of regenerative medicine who will mee...
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2018-11-16
ProTrans trial is approved for high dose treatment in the phase II part
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Swedish Medical Product Agency has approved the amendment for treatment of patients in the ProTrans-1 trial with high dose of ProTrans in the randomized placebo-controlled part. The ProTrans clinical trial is divided into a dose-scale part where 9 patients were treated with ProTrans during 2018. On October 25th, the Data Safety and Monitoring Board recommended the start of the second part of the trial with the dose that the study team found most appropriate. The safety of ProTrans seem well tolerated, NXTCL
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Swedish Medical Product Agency has approved the amendment for treatment of patients in the ProTrans-1 trial with high dose of ProTrans in the randomized placebo-controlled part. The ProTrans clinical trial is divided into...
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2018-11-14
NextCell Pharma's clinical trial on the TV3 Diabetes gala
Stem cell company NextCell Pharma AB ("NXTCL") announces that the ongoing clinical trial with ProTrans for the treatment of type 1 diabetes, tonight will be highlighted on the Diabetes Gala. A shorter clip will be shown on the gala and a longer version will be available on ViaPlay, Viafree and on the NXTCL website. The broadcast strats at 20:00.
Stem cell company NextCell Pharma AB ("NXTCL") announces that the ongoing clinical trial with ProTrans for the treatment of type 1 diabetes, tonight will be highlighted on the Diabetes Gala. A shorter clip will be shown on the gala and a longer version will be available on ViaPlay, Viafree and on...
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2018-11-12
Earlier announced directed share issue to Nordic Tech House AB registered at the Swedish Companies Registrations Office
NextCell Pharma AB ("NextCell") hereby announces that the directed share issue to Nordic Tech House AB (”NTH”) has been registered at the Swedish Companies Registrations Office (Bolagsverket). The newly issued shares are under lock-up. In total, 260 100 shares have been issued at a subscription price of SEK 5.767 per share, equivalent to 2.3 percent of votes and capital in NXTCL. The shares will be settled retrospectively. After the registration at the Swedish Companies Registrations Office, the total amount of shares in NXTCL are 11 486 456 and the share capital is SEK 2 354 723,48. NTH has
NextCell Pharma AB ("NextCell") hereby announces that the directed share issue to Nordic Tech House AB (”NTH”) has been registered at the Swedish Companies Registrations Office (Bolagsverket). The newly issued shares are under lock-up. In total, 260 100 shares have been issued at a subscription p...
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2018-11-09
Publication of annual report 2017/2018
NextCell Pharma AB hereby, on November 9th, 2018, publishes the annual report for the fiscal year 2017/2018. The annual report is available on the company’s website (www.nextcellpharma.com) and Spotlight Stock Market’s website (www.spotlightstockmarket.com).
NextCell Pharma AB hereby, on November 9th, 2018, publishes the annual report for the fiscal year 2017/2018. The annual report is available on the company’s website (www.nextcellpharma.com) and Spotlight Stock Market’s website (www.spotlightstockmarket.com)....
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2018-11-05
Application for clinical trial submitted to the Medical Products Agency, ProTrans-2.
NextCell Pharma AB ("NXTCL") today announced that a new application to conduct a clinical trial with ProTrans has been submitted to the Swedish Medical Products Agency. The purpose of the study is to evaluate repeated treatment with ProTrans, including patients with type 1 diabetes who participated in the dose escalating part of the original NXTCL trial. The ongoing clinical trial called ProTrans-1, was initiated with a dose escalation phase for 9 patients all followed for 12 months. After their last visit in the study, patients will be asked if they want to participate in a new study where
NextCell Pharma AB ("NXTCL") today announced that a new application to conduct a clinical trial with ProTrans has been submitted to the Swedish Medical Products Agency. The purpose of the study is to evaluate repeated treatment with ProTrans, including patients with type 1 diabetes who participat...
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2018-11-02
Update regarding targeted new issue to Nordic Tech House
NextCell Pharma (NXTCL), announces today that the Board, with the authorization of the Annual General Meeting of December 5, 2017, has decided to implement a directed new issue of Nordic Tech House AB ("NTH") of a maximum of approximately SEK 1.5 million. The reasons for the deviation from shareholders' pre-emption rights are to fulfil the company's commitment in accordance with an agreement with Nordic Tech House AB, which was concluded to provide the company with new owners of strategic importance. Current decision replaces previous resolutions on directed new issue from March 13, 2018,
NextCell Pharma (NXTCL), announces today that the Board, with the authorization of the Annual General Meeting of December 5, 2017, has decided to implement a directed new issue of Nordic Tech House AB ("NTH") of a maximum of approximately SEK 1.5 million. The reasons for the deviation from shareh...
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