Trial Outcomes & Findings for Effect Of Mesenchymal Stem Cells Transfusion on the Diabetic Peripheral Neuropathy Patients . (NCT NCT02387749)
NCT ID: NCT02387749
Last Updated: 2018-07-03
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
zero ( before) , 7 DAYS, 90 days
Results posted on
2018-07-03
Participant Flow
Participant milestones
| Measure |
Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy
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
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect Of Mesenchymal Stem Cells Transfusion on the Diabetic Peripheral Neuropathy Patients .
Baseline characteristics by cohort
| Measure |
Mesenchymal Stem Cells Transfusion in DPN Patients
n=10 Participants
This study was conducted on 10 patients with Diabetic peripheral neuropathy (DPN), 4 females and 6 males
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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41.20 years
STANDARD_DEVIATION 4.59 • n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Region of Enrollment
Egypt
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: zero ( before) , 7 DAYS, 90 daysPopulation: 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
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
Outcome measures
| Measure |
Measurement of b-FGF and v- EGF MEASURED BY ELISA
n=10 Participants
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
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Measurement of b-FGF, v-EGF MEASURED BY ELISA
b-FGF ZERO
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30.2 pg/ml
Standard Deviation 16.7
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Measurement of b-FGF, v-EGF MEASURED BY ELISA
b-FGF 7 DAYS
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55.4 pg/ml
Standard Deviation 12.3
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Measurement of b-FGF, v-EGF MEASURED BY ELISA
b-FGF 90 days
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30.3 pg/ml
Standard Deviation 14.8
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Measurement of b-FGF, v-EGF MEASURED BY ELISA
v- EGF ZERO
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428.7 pg/ml
Standard Deviation 125
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Measurement of b-FGF, v-EGF MEASURED BY ELISA
v- EGF 7 DAYS
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601.8 pg/ml
Standard Deviation 141.8
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Measurement of b-FGF, v-EGF MEASURED BY ELISA
v-EGF 90 DAYS
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371.5 pg/ml
Standard Deviation 121.9
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PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Measurement of b-FGF and v- EGF MEASURED BY ELISA
n=10 Participants
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
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
Tibial Motor Nerve conduction velocity zero
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43.6 m/sec
Standard Deviation 8.5
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
Tibial motor nerve conduction velocity 90 days
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44.4 m/sec
Standard Deviation 6.6
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
common peroneal motor nerve velocity at zero day
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43.8 m/sec
Standard Deviation 10.3
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
common peroneal motor nerve velocity at 90 day
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45.2 m/sec
Standard Deviation 12.3
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
Ulnar Motor Nerve conduction velocity at zero day
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56.0 m/sec
Standard Deviation 8.7
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
Ulnar Motor Nerve conduction velocity at 90 days
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54.2 m/sec
Standard Deviation 10.6
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
Ulnar sensory Nerve conduction velocity zero day
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52.0 m/sec
Standard Deviation 16.3
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
Ulnar sensory Nerve conduction velocity at 90 days
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51.2 m/sec
Standard Deviation 12.4
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
Sural Nerve conduction Velocity at zero day
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21.1 m/sec
Standard Deviation 22.7
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Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
Sural Nerve conduction Velocity at 90 days
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25.5 m/sec
Standard Deviation 27.0
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PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Measurement of b-FGF and v- EGF MEASURED BY ELISA
n=10 Participants
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
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|---|---|
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
Tibial Motor nerve conduction latency zero day
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4.4 msec
Standard Deviation 1.9
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
Tibial Motor nerve conduction latency 90 days
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4.1 msec
Standard Deviation 1.3
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
common peroneal motor nerve latency at zero day
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4.4 msec
Standard Deviation 1.8
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
common peroneal motor nerve latency at 90 day
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4.2 msec
Standard Deviation 1.1
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
Ulnar Motor Nerve conduction latency at zero day
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2.9 msec
Standard Deviation 0.8
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
Ulnar Motor Nerve conduction latency at 90 day
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2.9 msec
Standard Deviation 0.7
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
Ulnar sensory Nerve conduction latency zero day
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3.0 msec
Standard Deviation 1.0
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
Ulnar sensory Nerve conduction latency 90 days
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2.7 msec
Standard Deviation 0.8
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
Sural Nerve conduction latency at zero day
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2.2 msec
Standard Deviation 2.4
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Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
Sural Nerve conduction latency at 90 days
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2.5 msec
Standard Deviation 2.8
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PRIMARY outcome
Timeframe: base line(zero dya), 90 days after stem cells transfusionMeasuring 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
Outcome measures
| Measure |
Measurement of b-FGF and v- EGF MEASURED BY ELISA
n=10 Participants
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
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|---|---|
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
Tibial Motor nerve Amplitude zero day
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3.8 uv
Standard Deviation 4.0
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
Tibial Motor nerve Amplitude at 90 days
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3.4 uv
Standard Deviation 3.0
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
common peroneal motor nerve amplitude at zero day
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2.2 uv
Standard Deviation 1.9
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
common peroneal motor nerve amplitude at 90 days
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2.2 uv
Standard Deviation 1.2
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
Ulnar Motor Nerve conduction amplitude zero day
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5.4 uv
Standard Deviation 1.9
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
Ulnar Motor Nerve conduction amplitude at 90 days
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6.3 uv
Standard Deviation 1.8
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
Ulnar sensory Nerve conduction amplitude zero day
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23.1 uv
Standard Deviation 16.5
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
Ulnar sensory Nerve conduction amplitude at 90 day
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21.3 uv
Standard Deviation 11.6
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
Sural Nerve conduction amplitude at zero day
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5.2 uv
Standard Deviation 5.8
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Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
Sural Nerve conduction amplitude at 90 day
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7.3 uv
Standard Deviation 8.6
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SECONDARY outcome
Timeframe: base line (zero day) and 90 days after stem cells transfusionfasting, 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.
Outcome measures
| Measure |
Measurement of b-FGF and v- EGF MEASURED BY ELISA
n=10 Participants
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
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|---|---|
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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
fasting blood sugar zero
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211.30 mg/dl
Standard Deviation 61.92
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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
fasting blood sugar 90 days
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145.70 mg/dl
Standard Deviation 37.56
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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
2 hours post postprandial blood sugar Zero
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291.50 mg/dl
Standard Deviation 106.56
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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
2 hours post postprandial blood sugar 90 days
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190.30 mg/dl
Standard Deviation 56.42
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SECONDARY outcome
Timeframe: at base line (zero day) and 90 days after stem cells transfusionBlood 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
Outcome measures
| Measure |
Measurement of b-FGF and v- EGF MEASURED BY ELISA
n=10 Participants
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
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Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent %
HA1C Level Zero
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9.12 percent %
Standard Deviation 3.42
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Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent %
HA1C Level 90 days
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7.96 percent %
Standard Deviation 1.89
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Adverse Events
Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dina Mohammed Riad Ebrahim Abdelmagid
Cairo university, faculty of medicine
Phone: +201112052600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place