Drugs / ProTrans
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04896853 | May 2021 → Mar 2027 expected | acute respiratory distress syndrome, influenza, pneumonia, respiratory syncytial virus infectious disease | NextCell Pharma Ab | Active not recruiting | No outcome recorded |
| Phase 1/22 trials · 1 met primary | ||||||
| Phase 1/2 | NCT03973827 | May 2019 → Dec 2020 | type 1 diabetes mellitus | NextCell Pharma Ab | Completed | No outcome recorded |
| Phase 1/2 | NCT03406585 | Nov 2017 → Jul 2020 | type 1 diabetes mellitus | NextCell Pharma Ab | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT04869397 | Jun 2021 → May 2023 | COVID-19 | McGill University Health Centre/Research Institute of the McGill University Health Centre | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT05061030 Comparator | Jan 2022 → Sep 2028 expected | type 1 diabetes mellitus | Uppsala University Hospital | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-03-13 | NextCell Pharma Ab | Results ProTrans Phase II COVID-19 Trial Accepted for Publication in Cytotherapy nextcellpharma.com ↗
The study confirms the short-term safety of ProTrans in hospitalized patients receiving contemporary standard-of-care therapies. |
| 2026-02-03 | NextCell Pharma Ab | Results Seven-year follow-up data from ProTrans-Repeat demonstrate sustained disease-modifying effects of ProTrans in type 1 diabetes nextcellpharma.com ↗
NextCell Pharma AB (“NextCell” or the “Company”) today announces long-term follow-up data from the ProTrans-Repeat study showing sustained preservation of endogenous insulin production in patients with newly diagnosed type 1 diabetes. |
| 2026-01-15 | NextCell Pharma Ab | Results Six-year data demonstrate a durable disease-modifying effect of ProTrans in type 1 diabetes nextcellpharma.com ↗
NextCell Pharma AB (“NextCell” or the “Company”) today announces that six-year follow-up data indicate that a single infusion of ProTrans provides a long-lasting and clinically relevant preservation of endogenous insulin production in patients with newly-diagnosed type 1 diabetes. |
| 2025-04-24 | NextCell Pharma Ab | Results NextCell presents detailed analysis of the administrative report from ProTrans-Young nextcellpharma.com ↗
We can absolutely say that the drug product is safe for children and early indications are that yes, we can target earlier in the disease than previously thought |
| 2025-04-15 | NextCell Pharma Ab | Results NextCell CEO Mathias Svahn explains the latest results from ProTrans-YOUNG and his vision for the way forward nextcellpharma.com ↗
You published the subgroup analysis yesterday, and it was received rather lukewarmly by shareholders, to say the least. |
| 2025-04-07 | NextCell Pharma Ab | Results Subgroup Analysis: NextCell Presents Preliminary One-Year Results from the Older Age Group in ProTrans-Young nextcellpharma.com ↗
NextCell Pharma today announces preliminary one-year results from the older age group (12–21 years) in the ongoing clinical trial ProTrans-Young. |
| 2024-12-17 | NextCell Pharma Ab | Results Long-term Effects with Repeated ProTrans Treatment After 6 Years nextcellpharma.com ↗
We now demonstrate that 6 years after the first infusion, the high-dose group (n=3) retained, on average, 91% of their insulin production. |
| 2024-09-05 | NextCell Pharma Ab | Results Broader health benefits of ProTrans in treatment of type 1 diabetes nextcellpharma.com ↗
The results show the long-term safety of the treatment, the effect of preserving the patient's own insulin production and more health benefits in patients with type 1 diabetes (T1D), such as lower BMI and blood pressure. |
| 2024-05-28 | NextCell Pharma Ab | Results Single treatment with ProTrans demonstrates long-term therapeutic effect over 5 years nextcellpharma.com ↗
NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who were treated with a single dose of ProTrans five years ago in the randomized, placebo-controlled phase II study ProTrans-2 have retained significantly higher endogenous insulin production than patients who received placebo. |
| 2024-03-27 | NextCell Pharma Ab | Regulatory The Swedish Medical Products Agency approves subgroup analysis in NextCell's ProTrans-Young study nextcellpharma.com ↗
NextCell Pharma AB ("NextCell" or the "Company") today announces that the Swedish Medical Products Agency has approved an application to conduct a subgroup analysis of the treatment effect of ProTrans in 30 adolescents in the age group 12-21 years, treated in the ProTrans-Young study. |
| 2023-11-06 | NextCell Pharma Ab | Results Repeated treatment with ProTrans is immunologically safe nextcellpharma.com ↗
NextCell Pharma AB ("NextCell" or the "Company") today announces that multiple treatments with ProTrans cell therapy does not induce donor specific antibodies in type-1 diabetes patients. |
| 2023-08-08 | NextCell Pharma Ab | Results ProTrans and NextCell gain international attention nextcellpharma.com ↗
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. |
| 2023-03-28 | NextCell Pharma Ab | Results NextCell´s publication of the phase I/II clinical trial in type I diabetes accepted nextcellpharma.com ↗
The study, although small, presents strong data indicative of the effectiveness of ProTrans treatment in slowing diabetic disease development. |
| 2023-01-25 | NextCell Pharma Ab | Regulatory ProTrans study in COVID-19 expanded to include treatment of severe pneumonia induced by influenza A, RSV and HMP virus nextcellpharma.com ↗
NextCell Pharma AB ("NextCell") today announces that the Swedish Medical Products Agency has approved the expansion of their Swedish COVID-19 study, to include patients with severe pneumonia due to influenza A, respiratory syncytial virus (RSV) and human metapneumovirus (HMP). |
| 2023-01-18 | NextCell Pharma Ab | Regulatory Positive feedback on the paediatric plan of the EMA nextcellpharma.com ↗
NextCell Pharma AB ("NextCell") has received positive comments and recommendations for the pediatric investigational plan (PIP) submitted to the Europeans Medicines Agency’s (EMA) pediatric committee (PDCO). |
| 2022-10-27 | NextCell Pharma Ab | Results NextCell presentation of Interim analysis data today at 15:00 nextcellpharma.com ↗
On October 18 this year, an interim analysis after the second treatment was presented, which concludes that treatment with the highest dose gives significant the best long-term effect regarding the preservation of one's own insulin production. |
| 2022-10-24 | NextCell Pharma Ab | Results NextCell cell therapy shows long-term effect in two independent diabetes studies "ProTrans-Repeat" and "ProTrans-Obs" – live presentation nextcellpharma.com ↗
On October 18 this year, an interim analysis after the second treatment was presented, which concludes that treatment with the highest dose gives significant the best long-term effect regarding the preservation of one's own insulin production. |
| 2022-10-20 | NextCell Pharma Ab | Results ProTrans cell therapy provides long-term effect in type-1 diabetes with a single treatment nextcellpharma.com ↗
NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who 3 years ago were treated with ProTrans in the phase II study ProTrans-2 have maintained significantly higher endogenous insulin production than patients who received placebo, (63% compared to 23%). |
| 2022-10-18 | NextCell Pharma Ab | Results ProTrans cell therapy maintains insulin production effect 3.5 years after treatment nextcellpharma.com ↗
NextCell Pharma AB ("NextCell" or the "Company") today announces that type-1 diabetes patients receiving two treatments with a high dose of ProTrans cell therapy maintain a significantly higher endogenous insulin production than patients treated with low or medium doses. |
| 2022-08-25 | NextCell Pharma Ab | Regulatory ProTrans cell therapy to be granted patent protection beyond Europe nextcellpharma.com ↗
NextCell Pharma AB ("NextCell" or the "Company") today announces that the Japan Patent Office (JPO) has issued a notice of allowance relating to the patent entitled "Allogeneic Composition" (publication number JP2020543858A). |
All press releases naming this drug 33 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ProTrans | “Allogeneic Wharton's jelly-MSCs (WJ-MSC) will be provided by NextCell Pharma under the commercial name of ProTrans®.” NCT04869397 ↗ |
| Known as | Allogeneic Wharton's jelly-MSCs (WJ-MSC) | “Allogeneic Wharton's jelly-MSCs (WJ-MSC) will be provided by NextCell Pharma under the commercial name of ProTrans®.” NCT04869397 ↗ |
| Modality | Cell therapy | “Wharton´s Jelly derived allogenic mesenchymal stromal cells” NCT03973827 ↗ |
| Route | Intravenous | “allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes” NCT03406585 ↗ |