Results from the Older Age Cohort in the ProTrans-Young Paediatric Study Expected in Aprilv

March 13, 2025

NextCell Pharma AB ("NextCell" or "the Company") announces that the last patient in the older age cohort (12–21 years) of the clinical Phase II study, ProTrans-Young, has now completed their 12-month follow-up. The collected data is currently being compiled, and an administrative subgroup analysis is planned to be presented at the IDF World Diabetes Congress in Bangkok from April 7–10.

ProTrans-Young aims to evaluate the safety and efficacy of ProTrans, umbilical cord mesenchymal stromal cell treatment for newly-diagnosed type 1 diabetes in children and adolescents. The upcoming analysis represents an important interim readout of treatment response within the 12–21 year old age group. The purpose is to examine whether the treatment response in this age group follows the same trend as previously observed in adult patients. Results from the earlier ProTrans-T1D study in adults were published in 2023 in Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD; Carlsson et al., 2023).

It is important to note that the analysis of this subgroup will not include in-depth statistical testing, such as significance assessment using p-values. This decision has been made to ensure the statistical integrity of the study. Repeated analyses within a study can increase the risk of false-positive results, which is typically managed by adjusting the significance level (alpha). However, such an adjustment can reduce the study’s ability to detect true effects. To avoid this issue, the analysis is therefore limited to an overall trend assessment at this point.

Recruitment is ongoing for the younger age cohort in the ProTrans-Young study, children aged 7–11 years, with the goal of including all patients before the summer of 2025.

The study is being conducted in collaboration with Uppsala University under the leadership of Professor Per-Ola Carlsson, together with co-investigators Johnny Ludvigsson at Linköping University and Helena Elding Larsson at Lund University. Uppsala Clinical Research Center is responsible for data management.

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, CEO Cellaviva AB
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

The company's shares are listed on the Nasdaq First North Growth Market. RedEye AB is assigned as Certified Adviser.

About NextCell Pharma AB

NextCell is a cell therapy company in Phase II trials with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase III trial. In addition to type 1 diabetes. NextCell owns Cellaviva AB, Scandinavia’s largest private stem cell bank licensed by the Swedish Health Authority (IVO) to preserve and store stem cells from umbilical cord blood and umbilical cord tissue for family use. NextCell also owns QVance which will offer quality control analytics for advanced therapy developers. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology.

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2018-07-09
Publication of scientific article regarding the clinical trial with ProTrans
The stem cell company NextCell Pharma AB ("NXTCL") today announced, that a scientific article describing the ongoing clinical trial with ProTrans has been published in Clinical Trials in Degenerative Diseases (CTDD), a peer reviewed journal encompassing clinical trials, research, therapeutics and education within the field of degenerative diseases. The scientific article was written by Per-Ola Carlsson, principal investigator of the ongoing clinical study with ProTrans and Mathias Svahn, CEO of NXTCL The title of the article is: “Wharton’s jelly derived allogeneic mesenchymal stromal cells
The stem cell company NextCell Pharma AB ("NXTCL") today announced, that a scientific article describing the ongoing clinical trial with ProTrans has been published in Clinical Trials in Degenerative Diseases (CTDD), a peer reviewed journal encompassing clinical trials, research, therapeutics and...
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2018-07-03
NextCell applies for prediction methodology patent
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The stem cell company NextCell Pharma AB ("NXTCL") has submitted another patent application. This time regarding a method for predicting if a specific patient is susceptible to treatment with the drug candidate ProTrans. Since the beginning of 2017, NXTCL has performed preclinical experiments in ...
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2018-06-29
The Data and Safety Monitoring Board approves the usage of high-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 high-dose cohort. The treatment of all three patients in the medium-dose cohort with ProTrans has been assessed as safe using a one-month follow-up period. Now NXTCL is now able to recruit patients for the last dose cohort, which is the high-dose cohort. The recruitment of the last dose cohort is expected to take one
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 high-dose cohort. The...
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2018-06-28
Extended tissue establishment authorization
The stem cell company NextCell Pharma AB ("NXTCL") was inspected on 7th May 2018 by the Health and Care Inspectorate (IVO), which is the supervisor of tissue establishments. NXTCL has today received the inspection report that authorizes the business to continue without any changes being required. NXTCL acquired the tissue establishment authorization in 2014-11-19. The permit is reviewed every other year in connection with inspection. The operations were inspected 2016-01-20 and now by 2018-05-07, again with a positive outcome. Tissue establishment is an establishment where physical or
The stem cell company NextCell Pharma AB ("NXTCL") was inspected on 7th May 2018 by the Health and Care Inspectorate (IVO), which is the supervisor of tissue establishments. NXTCL has today received the inspection report that authorizes the business to continue without any changes being required....
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2018-05-18
Six patients now treated with NextCells ProTrans stem cells
NextCell Pharma AB ("NXTCL") announces that an additional three patients have been treated with ProTrans in the ongoing clinical phase I/II trial. In total 6 patients with type 1 diabetes in the low- and medium-dose-cohort have now undergone treatment. The trial performed with NXTCL's drug candidate ProTrans, is divided into two parts, the first part being a dose-escalation phase with 3 + 3 + 3 patients being treated with either a; low, medium or high dose of ProTrans. Now all patients in the low-dose-cohort and the medium-dose-cohort have been treated. After the 1-month follow-up of the
NextCell Pharma AB ("NXTCL") announces that an additional three patients have been treated with ProTrans in the ongoing clinical phase I/II trial. In total 6 patients with type 1 diabetes in the low- and medium-dose-cohort have now undergone treatment. The trial performed with NXTCL's drug candid...
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2018-04-30
Today NextCell Publishes its half-year report
NextCell Pharma AB ("NEXTCL", "NextCell") today released its half-year report (September 1, 2017 - February 28, 2018) By "NextCell" or "Company" is meant NextCell Pharma AB with organization number 556965-8361. Amount in brackets in the report refers to the corresponding period in the previous year. Note that the Company's fiscal year is September 1 - August 31. First half (2017-09-01 till 2018-02-28)  · Net sales amounted to SEK 391 204 (120 594). · Operating result amounted to SEK -7 524 256 (-4 863 506). · Cash and bank amounted to SEK 9 444 381 (4 124 396).        ·
NextCell Pharma AB ("NEXTCL", "NextCell") today released its half-year report (September 1, 2017 - February 28, 2018) By "NextCell" or "Company" is meant NextCell Pharma AB with organization number 556965-8361. Amount in brackets in the report refers to the corresponding period in the previous ye...
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2018-04-27
NextCell enters into Memorandum of Agreement with China General Consulting & Investment Co., Ltd.
NextCell Pharma AB ("NextCell") hereby announces that the company has entered a Memorandum of Agreement with China General Consulting & Investment Co., Ltd. (”CGCI”). The purpose of the agreement is to create a base for future co-operation. The agreement includes that the parties should prioritize working together when it comes to stem cell development and China, but is otherwise without claims or obligations and does not affect NextCell financially. NextCell has developed a patented applied for selection algorithm to ensure the selection and production of potent mesenchymal stem cells in
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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...
Read moreRead more