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Mesenchymal Stem Cells to Treat Type II Diabetes (UC-MSCs)

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ClinicalTrials.gov Identifier: NCT02302599
Recruitment Status : Unknown
Verified November 2014 by Yiming Mu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : November 27, 2014
Last Update Posted : November 27, 2014
Sponsor:
Information provided by (Responsible Party):
Yiming Mu, Chinese PLA General Hospital

Brief Summary:
Between umbilical cord mesenchymal stem cells by the secretion characteristics, secrete a variety of cytokines and its immune inhibition, promoted the islet cell repair and regeneration, improve the state of high blood sugar in the body.

Condition or disease Intervention/treatment Phase
Type II Diabetes Biological: Umbilical cord mesenchymal stem cells Biological: Controlled suspension liquid Phase 1

Detailed Description:
Between umbilical cord mesenchymal stem cells secrete a variety of cytokines, improve insulin target tissue insulin resistance, improve the body state of high blood sugar, reduce the metabolic disorder of islet progressive damage, ease or regeneration of the islet beta cells;Improve the micro environment, induced damage alpha cells into beta cells in the islet transformation, realize the islet beta cells in situ regeneration, reduce high blood sugar;Between mesenchymal stem cells have immunosuppressive effect, inhibition of T cell mediated immune response to beta cells, improve the micro environment of nutrition, promote islet cell repair and regeneration.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cell Infusion Therapy Between Efficacy and Safety of Chinese Type II Diabetic Subjects of Multicenter, Randomized, Double-blind, Controlled Study
Study Start Date : January 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Umbilical cord mesenchymal stem cells
Patients receive Umbilical cord mesenchymal stem cells in the absence of disease progression or unacceptable toxicity
Biological: Umbilical cord mesenchymal stem cells
Infusion treatment

Experimental: Controlled suspension liquid
Patients receive Controlled suspension liquid
Biological: Controlled suspension liquid
Infusion treatment




Primary Outcome Measures :
  1. Change in MSCs Level From Baseline to Week 48 From Baseline [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in Fasting Glucose Over Time [ Time Frame: 48 weeks from baseline ]

Other Outcome Measures:
  1. Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8% [ Time Frame: 48 weeks ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Who signed the informed consent form ages of 20 and 60 years old or less or more men or women (not pregnancy).
  2. 24.0 kg/m2 or less BMI 40.0 kg/m2 or less
  3. Type 2 diabetes duration 15 years or less.
  4. Before the screening, joint or combined with insulin, oral medications to treat more than six months, HbA1c st13 of 7%, by the replacement for the door insulin 30 (total daily dose of 0.6 to 0.6 U/Kg) with metformin therapy 12 weeks, 7.0% ﹤ HbA1c of 12% or less of the subjects
  5. Based C peptide, p 1 ng/ml

Exclusion Criteria:

  1. serious allergic constitution.
  2. according to the researcher's judgement, may endanger the safety of the subjects or solution compliance of any chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, respiratory disease, nerve diseases of the nervous system, blood system diseases, etc.
  3. according to the local label, any contraindications to metformin.
  4. Stage IV above, diabetic nephropathy (excluding IV) and fertile diabetic retinopathy.
  5. People with mental illness, patients with drug and alcohol abuse.
  6. Within 1 month, used or are using the sugar metabolism of drugs, such as corticosteroids, thiazide diuretics, oral contraceptives, tricyclic antidepressants, and so on.
  7. Within 3 months, participated in any other clinical subjects
  8. Pregnancy or breast-feeding women, pregnant women, preparation

Information from the National Library of Medicine

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): NCT02302599


Contacts
Contact: Haojie HAO +86(10)937917 haojieh@163.com

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100039
Contact: Haojie HAO    +86(10)937516    haojieh@163.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Director: weidong HAN Chinese PLA General Hospital
Principal Investigator: yiming MU Chinese PLA General Hospital