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

Phase 1

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Biological: MenSCs transplantation; Drug: exogenous indulin injection daily

• Registration Number: NCT01496339
• Lead Sponsor: S-Evans Biosciences Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2011-12-18
• Study First Submitted QC: 2011-12-18
• Study First Posted: 2011-12-21
• Study Start: 2012-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07
• Primary Completion: 2013-12
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stem cell infusion	MenSCs transplantation	-
Traditional therapy control	exogenous indulin injection daily	-

Primary Outcome Measures

Name	Time	Method
Glycosylated hemoglobin (HbA1c)	1 year

Secondary Outcome Measures

Name	Time	Method
The postprandial blood glucose	1 year
The random glucose level	2 years
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China