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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 1/2 Clinical Study of MenSCs Infusion in Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Biological: MenSCs transplantation
* Drug: exogenous indulin injection daily


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional therapy control<br> | Drug: exogenous indulin injection daily<br>* traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.<br>|
| Experimental: Stem cell infusion<br> | Biological: MenSCs transplantation<br>* 1×10^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin (HbA1c) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The acute reaction and severity of adverse events related to the stem cell infusion procedure |  | 2 years | 
| Number of severe and documented hypoglycemic events |  | 2 years | 
| C-peptide release test |  | 3 months | 
| The reduction in fasting blood glucose (FBG) |  | 1 year | 
| The increase in basal C-peptide |  | 1 year | 
| The postprandial blood glucose |  | 1 year | 
| The random glucose level |  | 2 years |