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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01496339
• Other study ID #: SEB-1213-T1DM
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 18, 2011
• Last updated: June 6, 2012
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2012
• Source: S-Evans Biosciences Co.,Ltd.
• Contact: Charlie Xiang, Professor
• Phone: 86-571-87236436
• Email: cxiang[@]zju.edu.cn
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
S-Evans Biosciences Co.,Ltd.	First Affiliated Hospital of Zhejiang University, Wenzhou Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated hemoglobin (HbA1c)		1 year	No
Secondary	The acute reaction and severity of adverse events related to the stem cell infusion procedure		2 years	No
Secondary	Number of severe and documented hypoglycemic events		2 years	No
Secondary	C-peptide release test		3 months	No
Secondary	The reduction in fasting blood glucose (FBG)		1 year	No
Secondary	The increase in basal C-peptide		1 year	No
Secondary	The postprandial blood glucose		1 year	No
Secondary	The random glucose level		2 years	No