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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: exogenous indulin injection daily; Biological: MenSCs transplantation

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Charlie Xiang, Professor; Phone Number: 86-571-87236436; Email: cxiang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University
      • Contact: Chengjiang Li, MD
      • Principal Investigator: Charlie Xiang, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glycosylated hemoglobin (HbA1c)	1 year

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: S-Evans Biosciences Co., Ltd.
• Collaborators: Wenzhou Medical University; Zhejiang University; Zhenjiang First People's Hospital
• Investigators: Principal Investigator: Charile Xiang, Professor, S-Evans Biosicences Co.,Ltd

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: December 18, 2011
• First Submitted That Met QC Criteria: December 18, 2011
• First Posted (Estimate): December 21, 2011

Study Record Updates

• Last Update Posted (Estimate): June 7, 2012
• Last Update Submitted That Met QC Criteria: June 6, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: SEB-1213-T1DM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No