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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 7, 2012
June 1, 2012
1.9 years
December 18, 2011
June 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Glycosylated hemoglobin (HbA1c)
1 year
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Traditional therapy control
ACTIVE COMPARATORStem cell infusion
EXPERIMENTALInterventions
1×10\^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.
traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- S-Evans Biosciences Co., Ltd.lead
- Zhejiang Universitycollaborator
- Wenzhou Medical Universitycollaborator
- Zhenjiang First People's Hospitalcollaborator
Study Sites (1)
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charile Xiang, Professor
S-Evans Biosicences Co.,Ltd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2011
First Posted
December 21, 2011
Study Start
January 1, 2012
Primary Completion
December 1, 2013
Study Completion
May 1, 2014
Last Updated
June 7, 2012
Record last verified: 2012-06