Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.
Cell Therapy Center
Amman, Jordan
RECRUITINGSafety of using allogenic ASC assessed by any adverse events
Patients will be assessed for any adverse events as a result of the injection.
Time frame: 6 months
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