Active — Not RecruitingPhase 1/2

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

Sweden66 participantsStarted 2022-01-14

Plain-language 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.

Who can participate

Age range7 Years – 21 Years

SexALL

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Inclusion criteria

✓. Written informed consent for participation of the study (for subjects below 18 years of age also from both caregivers), given before undergoing any study-specific procedures
✓. Clinical history compatible with type 1 diabetes diagnosed less than 6 months before enrolment
✓. In the first part of the study, six subjects, three between 7-11 and three between 12-18 years of age (both groups inclusive at both ends), will be included. The sixty subjects in the second part of the study are stratified by age (12-21 and 7-11 years, respectively) and randomized to one of two treatment arms (active or placebo), with a 6-month safety delay for the younger stratum.
✓. Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol.
✓. Fasting plasma C-peptide concentration \>0.12 nmol/L.
✓. Subjects of child-bearing potential must agree to using adequate contraception until one year after the administration of WJMSC/Placebo. Adequate contraception is as follows:
✓. oral (except low-dose gestagen (lynestrenol and noretisteron), injectable or implanted hormonal contraceptives.
✓. intrauterine device

Exclusion criteria

What they're measuring

Safety at one year evaluated as adverse events

Timeframe: One year

Safety at five years evaluated as adverse events

Timeframe: Five years

Efficacy measured as change in C-peptide Area under the curve to a mixed mealtolerance test.

Timeframe: One year

Trial details

NCT IDNCT05061030

SponsorUppsala University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09

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