To evaluate the safety and efficacy of Stem cells from human exfoliated teeth transplantation in patients with Islet function decreased significantly to provides scientific basis for further clinical studies to verify the safety and efficacy. On the basis of maintaining the original treatment, intravenous drip of dental pulp mesenchymal stem cells.
Basic treatment: The original treatment regimen was maintained. During the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped or patients still had frequent hypoglycemia). Stem cell therapy: Dosage: Stem cells from human exfoliated teeth were calculated at 0.11IU/kg body weight . Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment. Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Intravenous infusion of pulp mesenchymal stem cells
Changhai hospital
Shanghai, Shanghai Municipality, China
RECRUITINGTotal daily insulin dose
change from baseline during treatment
Time frame: baseline and 1,2,6 week and 2,3,6,9,12 month
glucose-c peptide release test
relative baseline change during treatment
Time frame: baseline and 1,2,6 week and 2,3,6,9,12 month
Islet function
c-peptide and proinsulin
Time frame: 1 year
Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia
Changes relative to baseline during treatment
Time frame: 1 year
Continuous dynamic blood glucose
Changes relative to baseline during treatment
Time frame: 1 year
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