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

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ClinicalTrials.gov Identifier: NCT02138331
Recruitment Status : Unknown
Verified May 2014 by Wael Fouad Nassar, General Committee of Teaching Hospitals and Institutes, Egypt.
Recruitment status was:  Enrolling by invitation
First Posted : May 14, 2014
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Wael Fouad Nassar, General Committee of Teaching Hospitals and Institutes, Egypt

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Biological: MSC exosomes. Phase 2 Phase 3

Detailed Description:
  • Twenty T1DM patients, age between 18-60 years with reduction of C-peptide chain more than 50%, C-peptide of more than 0.8 ng/mL at Screening and requiring insulin ≥0.4 IU per kg per day.
  • Twenty T1DM patients of the same entry selection criteria will be subjected to all steps except the microvesicles administration as a control group.
  • Study follow up period: Three months
  • Gender: Both males and females are included
  • Entry selection criteria include:

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.

- The primary end point will be the end of three months follow up. At day (0):All patients and controls will be subjected to the following investigations: Liver functions tests, kidney functions tests, HbA1c, glucose tolerance test (GTT), fasting and 2 hrs.post prandial blood glucose levels, C-peptide chain level and calculated total daily insulin dose.

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:

- The first dose will be purified exosomes, ranging between 40-180 nm, in a dose of the supernatant produced from (1.22-1.51) × 10 (6)/kg/IV.

(Characterization of exosomes:CD63, CD9, Alix, TSG 101, HSP 70).

- The second dose, after 7 days, will be the microvesicles, ranging between 180-1000 nm, in a dose of the supernatant produced from (1.22-1.51) × 10 (6)/kg/IV.

(Characterization of microvesicles: (Annexin V, Flotillin-2, selectin,integrin, CD40 metalloproteinase).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of The Effect of Cell-Free Cord Blood Derived Microvesicles On β-cell Mass in Type 1 Diabetes Mellitus (T1DM) Patients
Study Start Date : April 2014
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Exosomes
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
Other Names:
  • Extacellular vesicles
  • Microvesicles


Outcome Measures
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Primary Outcome Measures :
  1. Total daily insulin dose [ Time Frame: Three months ]
    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.


Secondary Outcome Measures :
  1. Pancreatic β-cell Mass [ Time Frame: 3 months ]
    Pancreatic β-cell Mass levels will be assessed before and after the 3 months study period of time.


Other Outcome Measures:
  1. Hemoglobin A1c [ Time Frame: Three months ]
    HbA1c levels before enrollment and at the end of the study


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138331


Locations
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Egypt
Sahel Teaching Hospital
Sahel, Cairo, Egypt, 11522
Sahel Teaching Hospital - General Committee of Teaching Hospitals and Institutes
Shubra, Cairo, Egypt, 11522
Sahel Teaching Hospital, General Commettee of Teaching Hospitals and Institutes.
Shubra, Cairo, Egypt, 11522
Sponsors and Collaborators
General Committee of Teaching Hospitals and Institutes, Egypt
Investigators
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Study Chair: Wael F Nassar, MD Sahel Teaching Hospital, General Committee of teaching Hospitals and Institutes
Study Director: Mervat El Ansary, MD Cairo University
Principal Investigator: 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
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Wael Fouad Nassar, Senior Consultant of Nephrology., General Committee of Teaching Hospitals and Institutes, Egypt
ClinicalTrials.gov Identifier: NCT02138331    
Other Study ID Numbers: 666666
Cell Free MSC Exo
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014
Keywords provided by Wael Fouad Nassar, General Committee of Teaching Hospitals and Institutes, Egypt:
Diabetes Mellitus Type 1
Microvesicles
Exosomes
Cord Blood
Mesenchymal Stem Cells
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases