ProTrans-1 / ProTrans-2: Wharton's jelly umbilical-cord mesenchymal stromal cells in recent-onset adult T1D
What this study tests
Combined Phase 1 dose-escalation (n = 9) and Phase 2 randomized, double-blind, placebo-controlled (n = 15) trial of a single fixed intravenous infusion of pooled Wharton's jelly mesenchymal stromal cells (ProTrans) in adults aged 18–40 within 2 years of Type 1 Diabetes diagnosis. Published in Diabetologia (Carlsson et al. 2023), showing only a 10% decline in 12-month MMTT C-peptide AUC on ProTrans versus a 47% decline on placebo (p < 0.05).
Editorial review: .
Registry checked: 2026-10-26. Registry’s own update: 2023-04-03.
Most recent recorded citation date: 2023-08 (month only). 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?
- Adults aged 18–40 diagnosed with Type 1 Diabetes within the preceding 24 months with fasting plasma C-peptide > 0.12 nmol/L (0.36 ng/mL). 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
- In the randomized Part 2 cohort (n = 15: 10 ProTrans at 200 million cells vs 5 placebo), endogenous insulin production (MMTT C-peptide AUC) declined by 10% at 12 months in the ProTrans group compared with 47% in the placebo group (p < 0.05), while median exogenous insulin needs changed by 0 U/day vs +10 U/day on placebo (p < 0.05). No treatment-related serious adverse events or HLA immunization occurred.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
- Safety and tolerability (treatment-emergent adverse events) over 12 months
- Relative change in stimulated C-peptide AUC (0–120 min mixed-meal tolerance test) from baseline to 12 months
The full picture
Study design and results
Combined Phase 1 open-label dose-escalation (ProTrans-1, n = 9, evaluating 25 million, 100 million, and 200 million pooled Wharton's jelly mesenchymal stromal cells) and Phase 2 randomized 2:1, double-blind, placebo-controlled (ProTrans-2, n = 15: 10 active at 200 million cells vs 5 placebo) trial in adults aged 18–40 within 2 years of Type 1 Diabetes diagnosis (fasting C-peptide > 0.12 nmol/L). Published in Diabetologia (Carlsson et al. 2023, PMID: 37221247), showing a 10% decline in 12-month MMTT C-peptide AUC in the ProTrans group versus a 47% decline in the placebo group (p < 0.05).
Sources
- [1]NCT03406585: Wharton's Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes · Trial registry · 2023-04-03
- [2]Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial · Peer-reviewed study · 2023-08 (month only) — Carlsson PO et al., Diabetologia 2023;66(8):1431-1441 (PMID 37221247; DOI 10.1007/s00125-023-05934-3).