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

NCT02138331 | Unknown Phase 2 DMC

• 2 other identifiers: 666666Cell Free MSC Exo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Diabetes Mellitus Type 1; Microvesicles; Exosomes; Cord Blood; Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

• 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.

  Three months

Secondary Outcomes (1)

• Pancreatic β-cell Mass

  3 months

Other Outcomes (1)

• Hemoglobin A1c

  Three months

Study Arms (1)

Exosomes

EXPERIMENTAL

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.

Interventions

MSC exosomes. BIOLOGICAL

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

Exosomes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 more than 0.8 ng/mL at Screening. BMI 20-40 kgm/m2.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (3)

Sahel Teaching Hospital

Sahel, Cairo Governorate, 11522, Egypt

Location

Sahel Teaching Hospital - General Committee of Teaching Hospitals and Institutes

Shubrā, Cairo Governorate, 11522, Egypt

Location

Sahel Teaching Hospital, General Commettee of Teaching Hospitals and Institutes.

Shubrā, Cairo Governorate, 11522, Egypt

Location

Related Publications (1)

• Ezquer F, Ezquer M, Contador D, Ricca M, Simon V, Conget P. The antidiabetic effect of mesenchymal stem cells is unrelated to their transdifferentiation potential but to their capability to restore Th1/Th2 balance and to modify the pancreatic microenvironment. Stem Cells. 2012 Aug;30(8):1664-74. doi: 10.1002/stem.1132.

  PMID: 22644660 RESULT

Related Links

• doi:10.1186/1741-7015-10-3 Cite this article as: Zhao et al.: Reversal of type 1 diabetes via islet b cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Medicine 2012 10:3.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Wael F Nassar, MD

  Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  STUDY CHAIR

• Mervat El Ansary, MD

  Cairo University

  STUDY DIRECTOR

• Abdelnaser A Saad, MSc

  Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  PRINCIPAL INVESTIGATOR

• Mosaad A Hamid, MD

  Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  PRINCIPAL INVESTIGATOR

• Wael M Esa, MSc

  Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  PRINCIPAL INVESTIGATOR

• Sameh Shawki, MSc

  Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  PRINCIPAL INVESTIGATOR

• Marwa Mohammad, MSc

  Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  PRINCIPAL INVESTIGATOR

• Tamer Shehab, MRCP

  Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes

  PRINCIPAL INVESTIGATOR

• Heba A Ghaffar, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant of Nephrology.

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

EG (3)