NCT05061030

Mesenchymal Stromal Cells to Treat Type 1 Diabetes in Children and Adolescents

A Double-blinded, Randomized, Parallel, Placebo-controlled Trial of Wharton's Jelly-derived Allogeneic Mesenchymal Stromal Cells to Treat Type 1 Diabetes in Children and Adolescents

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Uppsala University Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This is a combined phase 1 and 2 study in 66 subjects, male or female, between 7-21 years of age that have recently (\< 6 months) been diagnosed with type 1 diabetes. The first phase 1 part of the study includes six subjects openly receiving allogeneic Wharton's jelly derived mesenchymal stromal cells as the Advanced Therapy Medicinal Product (ATMP) Protrans, three each in the age ranges 7-11 and 12-18.The second part is a randomized, double-blinded placebo-controlled phase 2 study in parallel design comparing allogeneic Wharton's jelly derived mesenchymal stromal cells treatment (as Protrans) to placebo in children and adolescent subjects (7-21 years of age) diagnosed with type 1 diabetes, The primary objectives of this study will be to investigate the safety, tolerance and efficacy after an allogieneic infusion of Wharton's jelly derived mesenchymal stromal cells.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
BIOLOGICAL	the ATMP Protrans	Protrans consists of Wharton's jelly derived mesenchymal stromal cells

Timeline

• Start date: 2022-01-14
• Primary completion: 2028-09-01
• Completion: 2028-12-01
• First posted: 2021-09-29
• Last updated: 2024-12-05

Locations

1 site across 1 country: Sweden