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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MenSCs transplantation
exogenous indulin injection daily
Sponsored by
S-Evans Biosciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional therapy control

Stem cell infusion

Arm Description

Outcomes

Primary Outcome Measures

Glycosylated hemoglobin (HbA1c)

Secondary Outcome Measures

The acute reaction and severity of adverse events related to the stem cell infusion procedure
Number of severe and documented hypoglycemic events
C-peptide release test
The reduction in fasting blood glucose (FBG)
The increase in basal C-peptide
The postprandial blood glucose
The random glucose level

Full Information

First Posted
December 18, 2011
Last Updated
June 6, 2012
Sponsor
S-Evans Biosciences Co., Ltd.
Collaborators
Zhejiang University, Wenzhou Medical University, Zhenjiang First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01496339
Brief Title
Human Menstrual Blood-derived Mesenchymal Stem Cells Transplantation in Treating Type 1 Diabetic Patients
Official Title
Phase 1/2 Clinical Study of MenSCs Infusion in Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S-Evans Biosciences Co., Ltd.
Collaborators
Zhejiang University, Wenzhou Medical University, Zhenjiang First People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional therapy control
Arm Type
Active Comparator
Arm Title
Stem cell infusion
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MenSCs transplantation
Intervention Description
1×10^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.
Intervention Type
Drug
Intervention Name(s)
exogenous indulin injection daily
Intervention Description
traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.
Primary Outcome Measure Information:
Title
Glycosylated hemoglobin (HbA1c)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The acute reaction and severity of adverse events related to the stem cell infusion procedure
Time Frame
2 years
Title
Number of severe and documented hypoglycemic events
Time Frame
2 years
Title
C-peptide release test
Time Frame
3 months
Title
The reduction in fasting blood glucose (FBG)
Time Frame
1 year
Title
The increase in basal C-peptide
Time Frame
1 year
Title
The postprandial blood glucose
Time Frame
1 year
Title
The random glucose level
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Xiang, Professor
Phone
86-571-87236436
Email
cxiang@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charile Xiang, Professor
Organizational Affiliation
S-Evans Biosicences Co.,Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengjiang Li, MD
First Name & Middle Initial & Last Name & Degree
Charlie Xiang, Professor

12. IPD Sharing Statement

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

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