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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by S-Evans Biosciences Co.,Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Zhejiang University
Wenzhou Medical University
First Affiliated Hospital of Zhejiang University
Information provided by (Responsible Party):
S-Evans Biosciences Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01496339
First received: December 18, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Type 1 Diabetes Mellitus
Biological: MenSCs transplantation
Drug: exogenous indulin injection daily
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Clinical Study of MenSCs Infusion in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by S-Evans Biosciences Co.,Ltd.:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The acute reaction and severity of adverse events related to the stem cell infusion procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of severe and documented hypoglycemic events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • C-peptide release test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The reduction in fasting blood glucose (FBG) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The increase in basal C-peptide [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The postprandial blood glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The random glucose level [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: S-Evans Biosciences Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01496339     History of Changes
Other Study ID Numbers: SEB-1213-T1DM
Study First Received: December 18, 2011
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014