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Effect of Microvesicles and Exosomes Therapy on β-cell Mass in Type I Diabetes Mellitus (T1DM)

NCT02138331 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-05-14

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus Type 1

Interventions

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

Sponsors & Collaborators

  • General Committee of Teaching Hospitals and Institutes, Egypt

    lead OTHER_GOV

Principal Investigators

  • Wael F Nassar, MD · Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  • Mervat El Ansary, MD · Cairo University

  • Abdelnaser A Saad, MSc · Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  • Mosaad A Hamid, MD · Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  • Wael M Esa, MSc · Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  • Sameh Shawki, MSc · Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  • Marwa Mohammad, MSc · Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  • Tamer Shehab, MRCP · Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  • Heba A Ghaffar, MSc · Cairo University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-07-31
Completion
2014-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02138331 on ClinicalTrials.gov