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Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01413035
Recruitment Status : Unknown
Verified July 2011 by Shandong University.
Recruitment status was:  Recruiting
First Posted : August 9, 2011
Last Update Posted : August 9, 2011
Sponsor:
Information provided by:
Shandong University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Biological: MSC Phase 1 Phase 2

Detailed Description:

1. Intervention Details: Biological: umbilical cord/placenta-derived mesenchymal stem cells; Drug: 1. Oral Hypoglycemic Drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. 2. Insulins.

  1. 1st transplantation: after finishing all required examines according to protocol in Day 0, umbilical cord/placenta-derived MSCs are transplanted intravenously.
  2. 2nd transplantation: after finishing all required examines in Day 90, umbilical cord/placenta-derived-MSCs are transplanted intravenously if the effects of MSC are better than that before.
  3. At the same time, patients continue taking the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins which the patients have taken for controlling the higher blood sugar from Day 0 for 1 year. But the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar.

2. Detailed Description:

  1. To evaluate the feasibility and safety of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins.
  2. To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins.
  3. This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant and the oral hypoglycemic drugs or MSC transplant and insulins or MSC transplant and the combination of the oral hypoglycemic drugs and insulins (experimental group) or the oral hypoglycemic drugs or insulins or the combination of the oral hypoglycemic drugs and insulins (control group). Patients will undergo MSC transplant at the start of the study on Day 0 and take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. As control, some patients take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. At the same time, the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar. After 3 months, patients will receive the second MSC transplantation. After six and twelve months from the first transplantation, patients will be evaluated.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety/Efficacy Assessed Study on Transplantation Therapy Using Human Umbilical Cord/Placenta-derived Mesenchymal Stem Cells for Type 2 Diabetes Mellitus
Study Start Date : July 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : July 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MSC and the oral hypoglycemic drugs
1.0E+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.
 Biological: MSC
1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better.
Experimental: MSC and insulins
1.0E+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.
 Biological: MSC
1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better.
Experimental: MSC and the combination of drugs and insulins
1.0E+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.
 Biological: MSC
1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better.


Outcome Measures
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Primary Outcome Measures :
  1. To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus [ Time Frame: 1 year ]

    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.


Secondary Outcome Measures :
  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 [ Time Frame: 1 year ]
    To evaluate if there have occured the adverse everts such as fever, allergy, et al. and their severity.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 19≤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

Exclusion Criteria:

  • 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.
Contacts and Locations
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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): NCT01413035


Contacts
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Contact: chengyun zheng, Ph. D +86-531-85875635 chengyun.zheng@ki.se, kdx2002@126.com

Locations
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China, Shandong
Department of Hematology of the 2nd Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250033
Contact: chengyun zheng, Ph. D    +86-531-85875635    chengyun.zheng@ki.se, kdx2002@126.com   
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: chengyun zheng, Ph. D Department of Hematology of The 2nd Hospital of Shandong University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chengyun Zheng, Department of Hematology of the 2nd Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT01413035     History of Changes
Other Study ID Numbers: diabetes
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: July 2011

Keywords provided by Shandong University:
Diabetes
Diabetes Medicines: Oral Hypoglycemic Drugs and Insulins.
Umbilical Cord/placenta-Derived MSC
Transplantation

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs