NCT03973827

Wharton´s Jelly Derived Mesenchymal Stromal Cell Repeated Treatment of Adult Patients Diagnosed with Type I Diabetes

An Open Label, Parallel Single Centre Trial of Wharton's Jelly Derived Allogeneic Mesenchymal Stromal Cells Repeated Treatment to Preserve Endogenous Insulin Production in Adult Patients Diagnosed with Type 1 Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: NextCell Pharma Ab · Industry
• Sex: Male
• Age: 18 Years – 41 Years
• Healthy volunteers: Not accepted

Summary

An open label, parallel single centre trial of Wharton's Jelly derived allogenic mesenchymal stromal cells repeated treatment to preserve endogenous insulin production in adult patients diagnosed with type 1 diabetes

Detailed description

This is a phase (I)/II study, and the purpose of this study is to determine whether, in adult patients diagnosed for type 1 diabetes, a repeated allogeneic infusion of WJMSCs is safe and to study changes in beta-cell function, metabolic control and Diabetes Treatment Satisfaction. The study population will consist of 15 adult male patients, 18-41 years of age (inclusive at both ends) diagnosed (\<3,5 years) with type 1 diabetes mellitus.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
DRUG	ProTrans	Single infusion of 25, 100 or 200 million cells per patient.
OTHER	Control	No intervention. Control subjects.

Timeline

• Start date: 2019-05-17
• Primary completion: 2020-12-10
• Completion: 2024-11-20
• First posted: 2019-06-04
• Last updated: 2025-03-07

Locations

1 site across 1 country: Sweden