RecruitingPhase 1Phase 2NCT05061030

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

Sponsor

Uppsala University Hospital

Enrollment

66 participants

Start Date

Jan 14, 2022

Study Type

INTERVENTIONAL

Conditions

Type1diabetes

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.

Eligibility

Min Age: 7 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether an infusion of mesenchymal stromal cells (a type of stem cell from umbilical cord tissue) can help preserve insulin-producing cells in children and teens newly diagnosed with type 1 diabetes. The goal is to slow or stop the immune system from destroying these cells early in the disease. **You may be eligible if...** - You are aged 7–21 and were diagnosed with type 1 diabetes less than 6 months ago - You still have some insulin-producing cells (confirmed by a blood test called C-peptide) - You and your parents/guardians can consent and comply with study visits **You may NOT be eligible if...** - You were diagnosed with type 1 diabetes more than 6 months ago - You are pregnant or unwilling to use contraception during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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