N/A
N=10
Effect Of Mesenchymal Stem Cells Transfusion on the Diabetic Peripheral Neuropathy Patients .
Diabetic Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT02387749 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Measurement of b-FGF, v-EGF MEASURED BY ELISA — 30.2; 55.4; 30.3; 428.7 pg/ml — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mesenchymal stem cells (Genetic)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cairo University
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of b-FGF, v-EGF MEASURED BY ELISA |
30.2; 55.4; 30.3; 428.7; 601.8; 371.5 | 0.005 sig |
| PRIMARY Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study. |
43.6; 44.4; 43.8; 45.2; 56.0; 54.2 | — |
| PRIMARY Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study |
4.4; 4.1; 4.4; 4.2; 2.9; 2.9 | — |
| PRIMARY Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study. |
3.8; 3.4; 2.2; 2.2; 5.4; 6.3 | — |
| SECONDARY 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 |
211.30; 145.70; 291.50; 190.30 | — |
| SECONDARY Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent % |
9.12; 7.96 | — |
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
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02387749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.