Clinical trial NCT01496339: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: S-Evans Biosciences Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang University
name: Wenzhou Medical University
name: Zhenjiang First People's Hospital
First posted: 2011-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: 1 year
Secondary outcomes:
measure: The acute reaction and severity of adverse events related to the stem cell infusion procedure
timeFrame: 2 years
measure: Number of severe and documented hypoglycemic events
timeFrame: 2 years
measure: C-peptide release test
timeFrame: 3 months
measure: The reduction in fasting blood glucose (FBG)
timeFrame: 1 year
measure: The increase in basal C-peptide
timeFrame: 1 year
measure: The postprandial blood glucose
timeFrame: 1 year
measure: The random glucose level
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: S-Evans Biosicences Co.,Ltd
name: Charile Xiang, Professor
role: PRINCIPAL_INVESTIGATOR
References: