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Effect Of Mesenchymal Stem Cells Transfusion on the Diabetic Peripheral Neuropathy Patients .

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ClinicalTrials.gov Identifier: NCT02387749
Recruitment Status : Completed
First Posted : March 13, 2015
Results First Posted : October 11, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
dina mohammed riad, Cairo University

Study Description
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Brief Summary:
A debilitating consequence of diabetes mellitus (DM) is neuropathy which globally affects between 20 -30% of diabetic patients and up to 50% in other studies. The incidence of diabetic neuropathy (DN) is estimated to be up to 45% for type 2 diabetic patients and 59% for type 1diabetic patients in USA.(DN) is the most common complication of DM.The pathophysiology of DN is promoted by several risk factors: micro vascular disease, neural hypoxia, and hyperglycemia-induced effects.At the molecular level, the primary cause of diabetic complications is known to be hyperglycemia, which disrupts cellular metabolism by the formation of reactive oxygen species (ROS).In the aspect of nerve functions, ROS formation increases neuron's susceptibility to damage. In addition, hyperglycemia impedes production of angiogenic and neurotrophic growth factors, which are necessary for normal function of neurons and glial cells and maintenance of vascular structure.No definitive disease-modifying treatments have been to reverse DN. The current treatment focuses on tight glycemic control which can reduce potential risk factors for further nerve damage and DN-associated pain management.In many studies, deficiency of neurotrophic factors and lack of vascular support have been regarded as key factors in the development DN.Mesenchymal stem cells (MSCs) are particularly attractive therapeutic agents because of their ability to self-renew, differentiate into multi lineage cell types, and locally secrete angiogenic cytokines, including basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) .These factors were reported to prompt neovascularization and have support for neural regeneration.It was plausible that MSCs may also be an effective therapeutic agent for the DN treatment through the paracrine effects of bFGF (Shibata et al., 2008) and VEGF and their potential to differentiate into neural cells such as astrocytes, oligodendrocytes , and Schwann cells.The adherent nature of MSCs makes them easy to expand in culture and an attractive candidate to use in cell therapy.Therefore, cell therapy has recently emerged as an attractive therapeutic strategy to meet the needs of both neurotrophic and vascular deficiencies of DN.Proper diagnosis of DN depends on the pattern of sensory loss, reflex test, electrodiagnostic studies, and imaging

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Genetic: mesenchymal stem cells Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect Of Mesenchymal Stem Cells Transfusion on the Peripheral Neuropathy in Diabetic Patients Measured by Nerve Conduction.
Study Start Date : May 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: mesenchymal stem cells
The BM aspirate will be diluted at 6:1 ratio with phosphate buffer saline with 2 ml EDTA (30 ml BM aspirate+ 5 ml PBS/EDTA buffer).MNCs will be separated under aseptic conditions using a Ficoll. Hypaque desity gradient by centrifugation at 1800 rpm for 20 min then the MNCs will be plated in 40 ml(αMEM), serum free media; mesencult(MSCs culture),penicillin (100 U/ml),streptomycin(10 mg/ml),0.5 ml amphotericin B(all from Gibco BRL) and 10 ng/ml basic fibroblast growth factor (b-FGF)(R&D system, Minneapolis, MN) and will be incubated at 370 c in a humidified atmosphere containing 5% CO2 .after one day ,nonadherent cells will be cultured in the presence of Mesenchymal media for 3 weeks changed every week. After reaching 80% confluence the MSCs will be placed in 10 ml saline and infused IV.
 Genetic: mesenchymal stem cells
collection of stem cells by bone marrow biopsy from iliac crest, then culture for 1 month , then IV transfusion on 2 sessions to the same patient


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of b-FGF, v-EGF MEASURED BY ELISA [ Time Frame: zero ( before) , 7 DAYS, 90 days ]
    measurement of b-FGF and v-EGF MEASURED BY ELISA before (at zero), and after at (7 days, 90) days after stem cell transfusion to measure the effect of stem cell and its role in nerve regeneration

  2. Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study. [ Time Frame: base line(zero dya), 90 days after stem cells transfusion. ]
    Measuring nerve conduction velocities(NCV) in m/sec upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line(zero day) and 90 days after stem cells transfusion

  3. Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study [ Time Frame: base line(zero dya), 90 days after stem cells transfusion . ]
    Measuring nerve conduction latency in msec of upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line and 90 days after stem cells transfusion

  4. Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study. [ Time Frame: base line(zero dya), 90 days after stem cells transfusion ]

    Measuring nerve conduction amplitudes in uv of upper and lower limbs nerves(sensory and motor).

    lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory .

    upper limb nerves: ulnar nerve as motor and sensory. and compare at base line and 90 days after stem cells transfusion



Secondary Outcome Measures :
  1. Change of Levels of Fasting Blood Sugar and 2 Hours Post Prandial at Base Line ( Zero Day ) and After (90 Days) After Stem Cells Transfusion [ Time Frame: base line (zero day) and 90 days after stem cells transfusion ]
    fasting, 2 hours postprandial blood sugar measurement before at base line (zero day) and after (90 days) stem cells transfusion as a follow up and comparing the values.

  2. Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent % [ Time Frame: at base line (zero day) and 90 days after stem cells transfusion ]
    Blood tests before and after stem cells(90 days) transfusion and comparing the values in percent % which is reflecting the patient blood sugar control in the previous 3 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (Type I, type II) diabetic patients age range (18-45) years, with diabetic peripheral neuropathy proved by clinical assessment and nerve conduction who did not receive treatment for diabetic peripheral neuropathy.

Exclusion Criteria:

  • Decompensated cardiac, renal or liver disease. Associated autoimmune diseases Associated endocrinal diseases Pregnancy, usage of contraceptive pills or steroids.
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): NCT02387749


Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Mohamed Gamal ElDin Saadi, phd Cairo University
Principal Investigator: Dina Abdelmagid, MD, MRCP UK Cairo University
More Information
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Publications:

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Responsible Party: dina mohammed riad, Assistant Lecturer of Internal Medicine,faculty of medicine,Kasr Al Ainy hospital, Cairo University
ClinicalTrials.gov Identifier: NCT02387749     History of Changes
Other Study ID Numbers: FACULTY OF MEDICINE,CAIRO U
First Posted: March 13, 2015    Key Record Dates
Results First Posted: October 11, 2017
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by dina mohammed riad, Cairo University:
diabetic peripheral neuropathy
mesenchymal stem cells

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases