Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial
An erratum to this article was published (Diabetologia, Apr 2025 ↗)
Authors' conclusion
This study suggests that allogeneic Wharton's jelly-derived MSCs (ProTrans) is a safe treatment for recent-onset type 1 diabetes, with the potential to preserve beta cell function.
Study context
- Population
- Adults aged 18–40 years with type 1 diabetes diagnosed <2 years before enrolment and fasting plasma C-peptide >0.12 nmol/l; Karolinska University Hospital, Stockholm, Swedenrandomised part
- Participants
- 15 adults
- Comparison
- Allogeneic Wharton's jelly-derived mesenchymal stromal cells (MSCs) vs placebo
- ProTransn = ten
- Placebon = fivereference
- Primary endpoint
- Δ-change in C-peptide AUC for a mixed meal tolerance test vs baseline
- Follow-up
- 1 year
Methodological detailsPhase I/II, dose escalation followed by randomised part, double-blind, placebo-controlled, parallel design, single-centre, Dose escalation: three participants per dose cohort in the first part
- Phase I/II
- Dose escalation followed by randomised part
- Double-blind
- Placebo-controlled
- Parallel design
- Single-centre
- Dose escalation: three participants per dose cohort in the first part
Primary result
As reported in the abstract
Decline in C-peptide
P < 0.05
Secondary outcomes
| Outcome | Placebo | P value |
|---|---|---|
| Insulin requirements · 12 months | median 10 U/day | P < 0.05 |
Insulin requirements · 12 months
- Insulin needs did not change with ProTrans; increased with placebo
Safety
- No serious adverse events related to treatment; few adverse events (mainly mild upper respiratory tract infections) in both arms
Original publication
Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial. Diabetologia. Published 24 May 2023. doi:10.
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