For participants assigned to the treated arm, they will follow study regime below: Intervention treatment will last from Day 0 up to Month 24.
Day 0: Subjects will receive alemtuzumab (30mg iv single dose); anakinra (100 mg sc.); etanercept (50 mg sc.) and liraglutide (0.6 mg sc.).
Day 1: Subjects will receive plerixafor (0.24 mg/kg/day) sc. to mobilize CD34+ stem cells to peripheral blood.
Day 1: Continuing with anakinra 100mg sc. daily for 12 month; etanercept 50mg sc. twice weekly for first 3 months, and 50mg sc. weekly for another 9 months; liraglutide 0.6 mg sc. daily for 7 days, then 1.2 mg sc. daily (or up to 1.8mg daily) as tolerated for 24 months.

For participant assigned to the control arm, they will be monitored and tested for the first 12 months, and receive intervention treatment from Month 12 up to Month 24.
Month 12: Subjects will receive alemtuzumab (30mg iv single dose); anakinra (100 mg sc.); etanercept (50 mg sc.) and liraglutide (0.6 mg sc.).
Month 12 + 1 day: Subjects will receive plerixafor (0.24 mg/kg/day) sc.. Month 12 + 1 day: Continuing with anakinra 100mg sc. daily for 12 month; etanercept 50mg sc. twice weekly for first 3 months, and 50mg sc. weekly for another 9 months; liraglutide 0.6 mg sc. daily for 7 days, then 1.2 mg sc. daily (or up to 1.8mg daily) as tolerated for 12 months.

Diabetes Mellitus, Type 1

Systemic CD34+ stem cell mobilization for beta-cell repair

Plerixafor

Alemtuzumab

Anakinra

Etanercept

Liraglutide

University of Alberta

Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)

Autologous Hematopoietic Stem Cell Mobilization (Plerixafor) and Immunologic Reset in New Onset Type 1 Diabetes Mellitus

This AUC will be normalized by dividing it by 120 minutes (the number of minutes over which it is determined), and will be adjusted by inclusion of baseline C-peptide AUC as a covariate in the analysis.

A subject is considered a responder if at the given time point, the subject has: a) HbA1c ≤6.5% and b) mean daily insulin use < 0.5 IU/kg/day over 7 consecutive days during the 2 weeks preceding the visit.

Mean total daily insulin dose assessed over 7 consecutive days during 2 weeks preceding clinic visits

Proportion of subjects free from severe hypoglycemia reported frequency of hypoglycemia by Hypo Score and Lability Index and CGMS

Proportion of subjects who become C-peptide negative

Including GAD, ICA512, IA2A, ZnT8 and mIAA

Alberta Innovates Health Solutions

subcutaneous injection with 60 mg Denosumab once

oligospermia/phosphatase

Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)

Denosumab and Male Infertility: a RCT

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