Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Type 2 Diabetes
Safety/Efficacy Assessed Study on Transplantation Therapy Using Human Umbilical Cord/Placenta-derived Mesenchymal Stem Cells for Type 2 Diabetes Mellitus
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg for type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Jul 2011
Longer than P75 for phase_1 type-2-diabetes
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
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 5, 2011
CompletedFirst Posted
Study publicly available on registry
August 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 9, 2011
July 1, 2011
2.4 years
August 5, 2011
August 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus
To assess efficacy of MSC through comparing the change of ITT, Hemoglobin A1c, FBG, PBG, C-peptide levels and T cell subsets with that of baseline. 1. The change of insulin resistance index(ITT) compared with baseline. 2. Rate of reducing exogenous insulin requirement compared with baseline. 3. The change of Fast blood glucose (FBG) and Postmeal blood glucose (PBG) compared with baseline. 4. A reduction of ≥1% in HbA1c compared with baseline. 5. The change of C-peptide levels compared with baseline. 6. The change of T cell subsets compared with baseline.
1 year
Secondary Outcomes (1)
To evaluate the incidence and severity of adverse events of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus
1 year
Study Arms (3)
MSC and the oral hypoglycemic drugs
EXPERIMENTAL1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former oral hypoglycemic drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. and regulates the dosage for 1 year.
MSC and insulins
EXPERIMENTAL1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former insulins and regulates the dosage for 1 year.
MSC and the combination of drugs and insulins
EXPERIMENTAL1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former combination of the oral hypoglycemic drugs and insulins and regulates the dosage for 1 year.
Interventions
1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better.
Eligibility Criteria
You may qualify if:
- Free will taking part in the study and ability to provide written informed consent
- Type 2 diabetes mellitus (as guideline WHO, 1999)
- Age 18-80 years old, Male/Female
- ≤Body mass index (BMI)≤30㎏/㎡
- Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％
- Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance
- Not pregnant or nursing
- No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 mmol/L
- No active severe viral or fungus infection
You may not qualify if:
- Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction)
- Active infection requiring treatment
- Unexplained febrile illness
- Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection
- Psychiatric condition that would limit informed consent
- Patient has enrolled another clinical trial study within last 4 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hematology of the 2nd Hospital of Shandong University
Jinan, Shandong, 250033, China
Related Publications (1)
Kong D, Zhuang X, Wang D, Qu H, Jiang Y, Li X, Wu W, Xiao J, Liu X, Liu J, Li A, Wang J, Dou A, Wang Y, Sun J, Lv H, Zhang G, Zhang X, Chen S, Ni Y, Zheng C. Umbilical cord mesenchymal stem cell transfusion ameliorated hyperglycemia in patients with type 2 diabetes mellitus. Clin Lab. 2014;60(12):1969-76. doi: 10.7754/clin.lab.2014.140305.
PMID: 25651730DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
chengyun zheng, Ph. D
Department of Hematology of The 2nd Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 5, 2011
First Posted
August 9, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2013
Study Completion
July 1, 2014
Last Updated
August 9, 2011
Record last verified: 2011-07