A Phase 1/2 interventional study of MenSCs transplantation and exogenous indulin injection daily in Type 1 Diabetes Mellitus, sponsored by S-Evans Biosciences Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-07.
Sponsored by S-Evans Biosciences Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →S-Evans Biosciences Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: exogenous indulin injection daily
Biological: MenSCs transplantation
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.
Glycosylated 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
This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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S-Evans Biosciences Co., Ltd.