The purpose of this study is to investigate whether the treatment of human menstrual blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and effective.
Diabetes mellitus is chronic metabolic diease caused by absent or rejection insulin from pancreatic b cells.The traditional treatment strategies for diabetes are daily injections with insulin and transplantation of islets from cadaver. However, daily injuection is very inconvenient and there is a shortage of organs and life long immunosuppression. Therefore, such therapy can be offered to a very limited number of patients only. MSC-based therapeutic intervention has become an emerging strategy for the replacement of injured tissues. MSCs also have been noted to possess immunomodulatory effects in vivo. Thus, their potential for clinical use as a cell-based therapy should be focused and observation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
1×10\^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.
traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGGlycosylated hemoglobin (HbA1c)
Time frame: 1 year
The acute reaction and severity of adverse events related to the stem cell infusion procedure
Time frame: 2 years
Number of severe and documented hypoglycemic events
Time frame: 2 years
C-peptide release test
Time frame: 3 months
The reduction in fasting blood glucose (FBG)
Time frame: 1 year
The increase in basal C-peptide
Time frame: 1 year
The postprandial blood glucose
Time frame: 1 year
The random glucose level
Time frame: 2 years
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