Use of Stem Cells in Diabetes Mellitus Type 1

Study Overview
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Brief Summary
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Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus

Detailed Description
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Adipose derived mesenchymal stem cells (ASCs) are to be collected from blood group O donor, cells will be passaged to passage 5. Before release the sample will be subject to our release criteria which include: testing for any bacterial or fungal growth as well as endotoxin and mycoplasma. All these tests must be negative. In addition the cell count and viability (must be more than 80%) are done before release. Surface markers documentation is done on the cells before release using flow cytometry. The cells should be infused within 2 hours of release. The dose to is to be repeated after 6 months of a total of two doses in patients. Tests and follow up are to be one at week 12, 24 and 36 when the study is stopped. These cells will be injected intravenously into patients newly diagnosed with type 1 Diabetes Mellitus.

Official Title
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The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial

Conditions
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Diabetes Mellitus Type 1

Intervention / Treatment
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* Biological: Adipose mesenchymal cells with bone marrow mononuclear cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Patients with Type 1 Diabetes Mellitus. Age from 18 years to 35 years either gender. Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml C-Peptide at inclusion base line should not be less than 0.5 ng/ml No clinical evidence of renal, retinal, vascular or skin complications Body Mass Index not exceeding 30 Any HbA1c At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2) Informed Consent by patient Exclusion Criteria: Age less than 18 years and more than 35 years Pregnancy Married women or women expected to be married within the study period History of allergy, Cancer, bronchial asthma, liver disease or hepatitis Diabetic coma or pre-coma current or recent within the last 2 months C-Peptide less than 0.5 ng/ml Disease duration more than 3 yrs. Complication mentioned in 5 above in inclusion Non-consenting patient or withdrawal of consent. Bleeding disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose 1 mil/kg<br>Adipose mesenchymal cells with bone marrow mononuclear cells. Two doses with a 6 month interval of allogenic Adipose mesenchymal cells +1 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously. | Biological: Adipose mesenchymal cells with bone marrow mononuclear cells<br>* Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.<br>|
| Active Comparator: Dose 10 mil/kg<br>Adipose mesenchymal cells with bone marrow mononuclear cells. Two doses with a 6 month interval of allogenic Adipose mesenchymal cells +10 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously. | Biological: Adipose mesenchymal cells with bone marrow mononuclear cells<br>* Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of using allogenic ASC assessed by any adverse events | Patients will be assessed for any adverse events as a result of the injection. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1, Adipose derived mesenchymal stem cells