A Phase 2/3 interventional study of MSC exosomes. in Diabetes Mellitus Type 1, sponsored by General Committee of Teaching Hospitals and Institutes, Egypt. Status unknown at 3 sites in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-05-14.
Sponsored by General Committee of Teaching Hospitals and Institutes, Egypt · Phase 2/3, Interventional, and Treatment
Type 1 diabetes mellitus is strictly autoimmune mediated disease destructing the islets β-cell of the pancreas. Mesenchymal stem cells and its microvesicles are reported as an anti-inflammatory agents. We hypothesis that intravenous infusion of cell free umbilical cord-blood derived MSC microvesicles may reduce the inflammatory state and hence improve the β-cell mass as well as the glycemic control of the patients of T1DM.
UACR less than 300, BUN between 10-20 mg/dl, serum creatinin between 0.6-1.4 mg/dl and normal liver enzymes, normal serum bilirubin, normal serum albumin and coagulation profile). C-peptide of more than 0.8 ng/mL at Screening. BMI 20-40 kgm/m2 - Exclusion criteria: Other autoimmune diseases. Pregnancy. Previous treatment with stem cells. All patients and controls will be investigated for HBV, HCV \& HIV by PCR test before enrollment in the study and positivity for any of these parameters means exclusion of this patient from the study.
After three months (at the end of the study) the same investigations will be repeated.
Two intravenous infusions of cell free cord-blood derived mesenchymal stem cells [CB-MSC] microvesicles:
(Characterization of exosomes:CD63, CD9, Alix, TSG 101, HSP 70).
(Characterization of microvesicles: (Annexin V, Flotillin-2, selectin,integrin, CD40 metalloproteinase).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →General Committee of Teaching Hospitals and Institutes, Egypt is the lead sponsor of 31 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
The exosomes have exosome-associated proteins such as the tetraspanin proteins, CD9 and CD81, Alix, Tsg101, and RNA that consists primarily of short RNAs of less than 300 nm. Some of these RNAs are microRNAs that are predominantly pre-microRNAs..Additionally, CB-SC displayed very low immunogenicity as indicated by expression of a very low level of major histocompatibility complex (MHC) antigens and failure to stimulate the proliferation of allogeneic lymphocytes.
Biological: MSC exosomes.
Exosomes: (Size) 40-100 nm, (markers) CD63, CD9, Alix, TSG 101, HSP 70 Microvesicles: (Size) 100-1000 nm, (markers) Annexin V, Flotillin-2, selectin, integrin, CD40 metalloproteinase
Also known as: Extacellular vesicles, Microvesicles
Total daily insulin dose
All T1DM patients with identified pre-study insulin dose and exosomes and microvesicles will be given then weekly follow up of the total daily insulin dose will be measured. After 3 months We calculate the total daily dose of insulin that maintain the RBS levels between 120-160 mg/dl at any point of the evaluation period.
Time frame: Three months
Pancreatic β-cell Mass
Pancreatic β-cell Mass levels will be assessed before and after the 3 months study period of time.
Time frame: 3 months
Hemoglobin A1c
HbA1c levels before enrollment and at the end of the study
Time frame: Three months
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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General Committee of Teaching Hospitals and Institutes, Egypt