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

NCT ID: NCT01496339

Last Updated: 2012-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-05-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional therapy control

Group Type: ACTIVE_COMPARATOR

exogenous indulin injection daily

Intervention Type: DRUG

traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.

Stem cell infusion

Group Type: EXPERIMENTAL

MenSCs transplantation

Intervention Type: BIOLOGICAL

1×10\^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.

Interventions

MenSCs transplantation

1×10\^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.

Intervention Type: BIOLOGICAL

exogenous indulin injection daily

traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: collaborator

Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Zhenjiang First People's Hospital

OTHER

Sponsor Role: collaborator

S-Evans Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charile Xiang, Professor

Role: PRINCIPAL_INVESTIGATOR

S-Evans Biosicences Co.,Ltd

Locations

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Charlie Xiang, Professor

Role: CONTACT

cxiang@zju.edu.cn

86-571-87236436

Facility Contacts

Chengjiang Li, MD

Role: primary

Other Identifiers

SEB-1213-T1DM

Identifier Type: -

Identifier Source: org_study_id