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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Peripheral Neuropathy
Intervention Genetic: mesenchymal stem cells
Enrollment 10

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy
Hide Arm/Group Description collection: bone marrow biopsy from iliac crest. Separation of cells:The bone marrow aspirate will be diluted at a ratio of 6:1 with phosphate buffer saline (PBS) with 2 ml EDTA (30 ml BM aspirate+ 5 ml PBS/EDTA buffer). The 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 alpha-modi-field Eagle's medium (αMEM), serum free media; mesencult(Mesenchymal stem cell 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 37 c in a humidified atmosphere containing 5% CO2.after one day,non adherent cells will be cultured in the presence of Mesenchymal media for 3 weeks changed every 1 week. After reaching 80% confluence the MSCs will be placed in 10 ml saline and will be infused intravenously. on 2 sessions to the same patient
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Mesenchymal Stem Cells Transfusion in DPN Patients
Hide Arm/Group Description This study was conducted on 10 patients with Diabetic peripheral neuropathy (DPN), 4 females and 6 males
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
blood pressure all patients were normal blood pressure measurement routine lab investigations were normal to exclude other co-morbidites
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
41.20  (4.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Egypt Number Analyzed 10 participants
10
1.Primary Outcome
Title Measurement of b-FGF, v-EGF MEASURED BY ELISA
Hide Description 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
Time Frame zero ( before) , 7 DAYS, 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
b-FGF, V-EGF (pg/ml) measured at zero, 7 days after stem cell transfusion measured by ELISA to measure the effectiveness of stem cells and as an indication for nerve regeneration
Arm/Group Title Measurement of b-FGF and v- EGF MEASURED BY ELISA
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: pg/ml
b-FGF ZERO 30.2  (16.7)
b-FGF 7 DAYS 55.4  (12.3)
b-FGF 90 days 30.3  (14.8)
v- EGF ZERO 428.7  (125)
v- EGF 7 DAYS 601.8  (141.8)
v-EGF 90 DAYS 371.5  (121.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Measurement of b-FGF and v- EGF MEASURED BY ELISA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
2.Primary Outcome
Title Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
Hide Description 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
Time Frame base line(zero dya), 90 days after stem cells transfusion.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nerve Conduction Velocities of Nerves
Hide Arm/Group Description:

nerve conduction velocities of nerves examined measured in Upper limbs and Lower limbs nerves,motor and sensory

lower limb motor nerves: tibial and common peroneal lower limb sensory nerve : sural nerve

upper limb motor nerve: ulnar nerve upper limb sensory nerve: ulnar nerve

data measured at zero (before stem cell transfusion) and 90 days after stem cell transfusion

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: m/sec
Tibial Motor Nerve conduction velocity zero 43.6  (8.5)
Tibial motor nerve conduction velocity 90 days 44.4  (6.6)
common peroneal motor nerve velocity at zero day 43.8  (10.3)
common peroneal motor nerve velocity at 90 day 45.2  (12.3)
Ulnar Motor Nerve conduction velocity at zero day 56.0  (8.7)
Ulnar Motor Nerve conduction velocity at 90 days 54.2  (10.6)
Ulnar sensory Nerve conduction velocity zero day 52.0  (16.3)
Ulnar sensory Nerve conduction velocity at 90 days 51.2  (12.4)
Sural Nerve conduction Velocity at zero day 21.1  (22.7)
Sural Nerve conduction Velocity at 90 days 25.5  (27.0)
3.Primary Outcome
Title Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
Hide Description 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
Time Frame base line(zero dya), 90 days after stem cells transfusion .
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nerve Conduction Latency of Nerves
Hide Arm/Group Description:
nerve conduction latency of nerves examined measured in Upper limbs and Lower limbs nerves,motor and sensory lower limb motor nerves: tibial and common peroneal lower limb sensory nerve : sural nerve upper limb motor nerve: ulnar nerve upper limb sensory nerve: ulnar nerve data measured at zero (before stem cell transfusion) and 90 days after stem cell transfusion
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: msec
Tibial Motor nerve conduction latency zero day 4.4  (1.9)
Tibial Motor nerve conduction latency 90 days 4.1  (1.3)
common peroneal motor nerve latency at zero day 4.4  (1.8)
common peroneal motor nerve latency at 90 day 4.2  (1.1)
Ulnar Motor Nerve conduction latency at zero day 2.9  (0.8)
Ulnar Motor Nerve conduction latency at 90 day 2.9  (0.7)
Ulnar sensory Nerve conduction latency zero day 3.0  (1.0)
Ulnar sensory Nerve conduction latency 90 days 2.7  (0.8)
Sural Nerve conduction latency at zero day 2.2  (2.4)
Sural Nerve conduction latency at 90 days 2.5  (2.8)
4.Primary Outcome
Title Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
Hide Description

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

Time Frame base line(zero dya), 90 days after stem cells transfusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nerve Conduction Amplitudes of Nerves
Hide Arm/Group Description:

nerve conduction amplitudes of nerves examined measured in Upper limbs and Lower limbs nerves,motor and sensory lower limb motor nerves: tibial and common peroneal, lower limb sensory nerve : sural nerve.

upper limb motor nerve: ulnar nerve motor , upper limb sensory nerve: ulnar nerve sensory data measured at zero (before stem cell transfusion) and 90 days after stem cell transfusion

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: uv
Tibial Motor nerve Amplitude zero day 3.8  (4.0)
Tibial Motor nerve Amplitude at 90 days 3.4  (3.0)
common peroneal motor nerve amplitude at zero day 2.2  (1.9)
common peroneal motor nerve amplitude at 90 days 2.2  (1.2)
Ulnar Motor Nerve conduction amplitude zero day 5.4  (1.9)
Ulnar Motor Nerve conduction amplitude at 90 days 6.3  (1.8)
Ulnar sensory Nerve conduction amplitude zero day 23.1  (16.5)
Ulnar sensory Nerve conduction amplitude at 90 day 21.3  (11.6)
Sural Nerve conduction amplitude at zero day 5.2  (5.8)
Sural Nerve conduction amplitude at 90 day 7.3  (8.6)
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame base line (zero day) and 90 days after stem cells transfusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blood Tests Measured Before and After Stem Cell Transfusion
Hide Arm/Group Description:
Plasma biochemical blood measurements will be determined by standard laboratory procedures in the central lab at clinical pathology department, Kasr Alaini hospital) Fasting blood glucose level, 2 hours postprandial.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mg/dl
fasting blood sugar zero 211.30  (61.92)
fasting blood sugar 90 days 145.70  (37.56)
2 hours post postprandial blood sugar Zero 291.50  (106.56)
2 hours post postprandial blood sugar 90 days 190.30  (56.42)
6.Secondary Outcome
Title Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent %
Hide Description 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
Time Frame at base line (zero day) and 90 days after stem cells transfusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HA1C Measurment Before and Afterr Stem Cell
Hide Arm/Group Description:
as a cumulative effect of patient control we measured HA1C at zero level and 90 days after stem cell transfusion in %
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percent %
HA1C Level Zero 9.12  (3.42)
HA1C Level 90 days 7.96  (1.89)
Time Frame 3 months
Adverse Event Reporting Description

monitoring to mainly anaphylaxis and risk of infection which are the main side effects after stem cells infusion were recorded and excluded.

regular follow up monthly up to 3 months recorded without serious side effects.

 
Arm/Group Title Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy
Hide Arm/Group Description collection: bone marrow biopsy from iliac crest. Separation of cells:The bone marrow aspirate will be diluted at a ratio of 6:1 with phosphate buffer saline (PBS) with 2 ml EDTA (30 ml BM aspirate+ 5 ml PBS/EDTA buffer). The 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 alpha-modi-field Eagle's medium (αMEM), serum free media; mesencult(Mesenchymal stem cell 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 37 c in a humidified atmosphere containing 5% CO2.after one day,non adherent cells will be cultured in the presence of Mesenchymal media for 3 weeks changed every 1 week. After reaching 80% confluence the MSCs will be placed in 10 ml saline and will be infused intravenously. on 2 sessions to the same patient
All-Cause Mortality
Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy
Affected / at Risk (%)
Total   0/10 (0.00%) 
patients are not so co-operative regarding stem cell collection by bone marrow biopsy, Lab requirements for stem cell culture and follow up are limited to the university lab with expensive equipment and kits The sample is small
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dina Mohammed Riad Ebrahim Abdelmagid
Organization: Cairo university, faculty of medicine
Phone: +201112052600
Publications:
Responsible Party: dina mohammed riad, Cairo University
ClinicalTrials.gov Identifier: NCT02387749     History of Changes
Other Study ID Numbers: FACULTY OF MEDICINE,CAIRO U
First Submitted: March 1, 2015
First Posted: March 13, 2015
Results First Submitted: August 11, 2016
Results First Posted: October 11, 2017
Last Update Posted: July 3, 2018