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

S-Evans Biosciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Biological: MenSCs transplantation; Drug: exogenous indulin injection daily

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01496339

SEB-1213-T1DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Traditional therapy control

Active Comparator group

Treatment:

Drug: exogenous indulin injection daily

Stem cell infusion

Experimental group

Treatment:

Biological: MenSCs transplantation