Human Menstrual Blood-derived Mesenchymal Stem Cells Transplantation in Treating Type 1 Diabetic Patients
This study is currently recruiting participants.
Verified June 2012 by S-Evans Biosciences Co.,Ltd.
Sponsor:
S-Evans Biosciences Co.,Ltd.
Collaborators:
Zhejiang University
Wenzhou Medical College
Zhenjiang First People's Hospital
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
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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
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 College
Zhenjiang First People's Hospital
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 May 16, 2013