NCT02387749

Effect Of Mesenchymal Stem Cells Transfusion on the Peripheral Neuropathy in Diabetic Patients Measured by Nerve Conduction.

Completed NA Results posted Last updated 2 July 2018

What this trial tests

NA trial testing mesenchymal stem cells in Diabetic Peripheral Neuropathy in 10 participants. Completed in 1 December 2016.

Timeline

1 May 2014

Primary endpoint
1 August 2016

1 December 2016

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 May 2014
Primary completion	1 August 2016
Estimated completion	1 December 2016

Drugs / interventions tested

• mesenchymal stem cells — full drug profile →

Conditions studied

• Diabetic Peripheral Neuropathy — all drugs for Diabetic Peripheral Neuropathy →

Sponsor

Cairo University

Who can join

Adults 18 to 45, any sex, with Diabetic Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Challenges and advances in clinical applications of mesenchymal stromal cells.
   Zhou T, Yuan Z, Weng J, Pei D, et al · · 2021 · cited 489× · PMID 33579329 · DOI 10.1186/s13045-021-01037-x
2. Comparing the Therapeutic Potential of Stem Cells and their Secretory Products in Regenerative Medicine.
   Foo JB, Looi QH, Chong PP, Hassan NH, et al · · 2021 · cited 89× · PMID 34422061 · DOI 10.1155/2021/2616807
3. Pharmacokinetic characteristics of mesenchymal stem cells in translational challenges.
   Shan Y, Zhang M, Tao E, Wang J, et al · · 2024 · cited 47× · PMID 39271680 · DOI 10.1038/s41392-024-01936-8
4. Stem Cells in Clinical Trials on Neurological Disorders: Trends in Stem Cells Origins, Indications, and Status of the Clinical Trials.
   Namiot ED, Niemi JVL, Chubarev VN, Tarasov VV, et al · · 2022 · cited 18× · PMID 36232760 · DOI 10.3390/ijms231911453
5. Advances in therapies using mesenchymal stem cells and their exosomes for treatment of peripheral nerve injury: state of the art and future perspectives.
   Aldali F, Deng C, Nie M, Chen H. · · 2025 · cited 16× · PMID 39435603 · DOI 10.4103/nrr.nrr-d-24-00235
6. Efficacy of autologous bone marrow mononuclear cell transplantation therapy in patients with refractory diabetic peripheral neuropathy.
   Mao H, Wei W, Fu XL, Dong JJ, et al · · 2019 · cited 13× · PMID 30628954 · DOI 10.1097/cm9.0000000000000009
7. Cellular microenvironment: a key for tuning mesenchymal stem cell senescence.
   Sun W, Lv J, Guo S, Lv M. · · 2023 · cited 12× · PMID 38111850 · DOI 10.3389/fcell.2023.1323678
8. Unveiling Mesenchymal Stem Cells' Regenerative Potential in Clinical Applications: Insights in miRNA and lncRNA Implications.
   Jankowski M, Farzaneh M, Ghaedrahmati F, Shirvaliloo M, et al · · 2023 · cited 8× · PMID 37947637 · DOI 10.3390/cells12212559