ProTrans-Young: randomized placebo-controlled trial of Wharton's jelly MSCs in children and adolescents with new-onset T1D
What this study tests
Investigator-initiated Phase 1/2 trial at Uppsala University evaluating a single intravenous infusion of pooled Wharton's jelly mesenchymal stromal cells (ProTrans) in 66 children and adolescents aged 7–21 with newly diagnosed Type 1 Diabetes. Fully enrolled and in active follow-up through 2028.
Editorial review: .
Registry checked: 2026-10-26. Registry’s own update: 2026-04-28.
Most recent recorded citation date: 2026-04-28. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Children, adolescents, and young adults aged 7–21 diagnosed with Stage 3 Type 1 Diabetes within the preceding 6 months with residual endogenous C-peptide. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- Phase 1b open-label safety cohorts in adolescents aged 12–18 (n = 6) and children aged 7–11 (n = 6) cleared safety review with no serious treatment-related adverse events. In April 2025, interim 12-month data from the older 12–21 randomized subgroup showed favorable safety and numerical C-peptide preservation trends, though prolonged honeymoon C-peptide retention in both arms masked statistically significant 1-year group separation; full 7–11 and 12–21 readouts are pending.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Incidence of treatment-related adverse events (Phase 1b safety cohort, n = 12)
- Change from baseline to 12 months in MMTT stimulated C-peptide AUC (Phase 2 randomized cohort, n = 54)
The full picture
Study design
Investigator-initiated combined Phase 1b open-label safety (n = 12) and Phase 2 randomized 1:1, double-blind, placebo-controlled (n = 54) trial at Uppsala, Linköping, and Lund Universities evaluating a single intravenous infusion of pooled Wharton's jelly mesenchymal stromal cells (ProTrans) in 66 children and adolescents aged 7–21 with newly diagnosed Type 1 Diabetes (<6 months from diagnosis). Enrollment completed in 2025, with 1-year and 5-year follow-up ongoing through September 2028.
Sources
- [1]