Human Menstrual Blood-derived Mesenchymal Stem Cells Transplantation in Treating Type 1 Diabetic Patients

• The acute reaction and severity of adverse events related to the stem cell infusion procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Number of severe and documented hypoglycemic events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• C-peptide release test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• The reduction in fasting blood glucose (FBG) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The increase in basal C-peptide [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The postprandial blood glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The random glucose level [ Time Frame: 2 years ] [ Designated as safety issue: No ]

• The acute reaction and severity of adverse events related to the stem cell infusion procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Number of severe and documented hypoglycemic events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• C-peptide release test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• The reduction in fasting blood glucose (FBG) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The increase in basal C-peptide [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The postprandial blood glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The glucose tolerance test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• The random glucose level [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

• Biological: MenSCs transplantation
  1×10^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.
• Drug: exogenous indulin injection daily
  traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.

• Active Comparator: Traditional therapy control
  Intervention: Drug: exogenous indulin injection daily
• Experimental: Stem cell infusion
  Intervention: Biological: MenSCs transplantation

Inclusion Criteria:

• male and female patients at the age of 18 to 75.
• agreement to receive written informed consent.
• voluntary submission to the procedures of the study protocol.
• clinical diagnosis is classified to type 1 diabetes(T1DM).
• T1DM duration ≥ 1 and ≤ 20 years from the time of enrollment.

Exclusion Criteria:

• renal dysfunction, eye disease or other organ disease.
• cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
• pregnancy
• mental disorders
• hepatitis C, HIV, RPR,active tuberculosis or blood diseases
• any malignancy
• any other severe diseases that could potentially influence the infusion results

• Zhejiang University
• Wenzhou Medical College
• Zhenjiang First People's Hospital