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

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ClinicalTrials.gov Identifier: NCT01496339
Recruitment Status : Unknown
Verified June 2012 by S-Evans Biosciences Co.,Ltd..
Recruitment status was:  Recruiting
First Posted : December 21, 2011
Last Update Posted : June 7, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Biological: MenSCs transplantation Drug: exogenous indulin injection daily Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Clinical Study of MenSCs Infusion in Type 1 Diabetes
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Traditional therapy control Drug: exogenous indulin injection daily
traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.
Experimental: Stem cell infusion Biological: MenSCs transplantation
1×10^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.


Outcome Measures

Primary Outcome Measures :
  1. Glycosylated hemoglobin (HbA1c) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The acute reaction and severity of adverse events related to the stem cell infusion procedure [ Time Frame: 2 years ]
  2. Number of severe and documented hypoglycemic events [ Time Frame: 2 years ]
  3. C-peptide release test [ Time Frame: 3 months ]
  4. The reduction in fasting blood glucose (FBG) [ Time Frame: 1 year ]
  5. The increase in basal C-peptide [ Time Frame: 1 year ]
  6. The postprandial blood glucose [ Time Frame: 1 year ]
  7. The random glucose level [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496339


Contacts
Contact: Charlie Xiang, Professor 86-571-87236436 cxiang@zju.edu.cn

Locations
China, Zhejiang
The First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Chengjiang Li, MD         
Principal Investigator: Charlie Xiang, Professor         
Sponsors and Collaborators
S-Evans Biosciences Co.,Ltd.
Zhejiang University
Wenzhou Medical University
First Affiliated Hospital of Zhejiang University
Investigators
Principal Investigator: Charile Xiang, Professor S-Evans Biosicences Co.,Ltd
More Information

Responsible Party: S-Evans Biosciences Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01496339     History of Changes
Other Study ID Numbers: SEB-1213-T1DM
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases