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

December 18, 2011
June 6, 2012
January 2012
December 2013   (final data collection date for primary outcome measure)
Glycosylated hemoglobin (HbA1c) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01496339 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 glucose tolerance test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The random glucose level [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Biological: MenSCs transplantation
    1×10^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.
  • Drug: exogenous indulin injection daily
    traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.
  • Active Comparator: Traditional therapy control
    Intervention: Drug: exogenous indulin injection daily
  • Experimental: Stem cell infusion
    Intervention: Biological: MenSCs transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Charlie Xiang, Professor 86-571-87236436 cxiang@zju.edu.cn
China
 
NCT01496339
SEB-1213-T1DM
Yes
S-Evans Biosciences Co.,Ltd.
S-Evans Biosciences Co.,Ltd.
  • Zhejiang University
  • Wenzhou Medical University
  • First Affiliated Hospital of Zhejiang University
Principal Investigator: Charile Xiang, Professor S-Evans Biosicences Co.,Ltd
S-Evans Biosciences Co.,Ltd.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP