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

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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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.
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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 |
- 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
- 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
- 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
- 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
- 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.
- 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

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

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
Study Chair: | Mohamed Gamal ElDin Saadi, phd | Cairo University | |
Principal Investigator: | Dina Abdelmagid, MD, MRCP UK | Cairo University |
Responsible Party: | dina mohammed riad, Assistant Lecturer of Internal Medicine,faculty of medicine,Kasr Al Ainy hospital, Cairo University |
ClinicalTrials.gov Identifier: | NCT02387749 |
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 |
diabetic peripheral neuropathy mesenchymal stem cells |
Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |