Type 1 Diabetes Mellitus
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALMenSCs transplantation
1×10\^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.
DRUGexogenous indulin injection daily
traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.
Sponsors
Zhejiang University
Wenzhou Medical University
Zhenjiang First People's Hospital
S-Evans Biosciences Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin (HbA1c) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 acute reaction and severity of adverse events related to the stem cell infusion procedure | 2 years |
| The postprandial blood glucose | 1 year |
| The random glucose level | 2 years |
| The increase in basal C-peptide | 1 year |
Countries
China
Contacts
Primary ContactCharlie Xiang, Professor
Outcome results
None listed