NCT03406585

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

A Double-blinded, Randomized, Placebo-controlled Trial With Wharton's Jelly Derived Allogeneic Mesenchymal Stromal Cells (WJMSCs) for Preserving Endogenous Insulin Production in Adult Patients Diagnosed for Type 1 Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: NextCell Pharma Ab · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To investigate the safety and tolerance after allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes.

Detailed description

This is a combined phase I and phase II study, where the first part is an open, dose escalating study consisting of 9 male patients, 18-40 years of age. The second part is a randomized, double-blinded, placebo-controlled, phase I/II study in parallel design comparing allogeneic WJMSC treatment to placebo in adult patients diagnosed with type 1 diabetes. Besides safety, preservation of endogenous insulin production (measured as C-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed. A total number of 24 patients will be enrolled in the study and followed for one year after WJMSC/placebo treatment. Patients 18-40 years of age, both male and female, diagnosed for type 1 diabetes will be eligible. Providing informed consent and fulfillment of inclusion criteria and no exclusion criteria, they will within two years of diagnosis be randomized.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ProTrans: Allogeneic transplantation with WJMSCs	The drug is a cell suspension with allogeneic mesenchymal stromal cells derived from umbilical cord tissue.
DRUG	Placebos	Placebo treatment

Timeline

• Start date: 2017-11-28
• Primary completion: 2020-07-01
• Completion: 2020-09-04
• First posted: 2018-01-23
• Last updated: 2023-04-03

Locations

1 site across 1 country: Sweden