Diabetic Peripheral NeuropathyNCT02387749

Effect Of Mesenchymal Stem Cells Transfusion on the Diabetic Peripheral Neuropathy Patients .

A study testing mesenchymal stem cells in people with Diabetic Peripheral Neuropathy, run by Cairo University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Diabetic Peripheral Neuropathy
What is being tested?: mesenchymal stem cells
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: May 2014to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

(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.

Who cannot join

Decompensated cardiac, renal or liver disease. Associated autoimmune diseases Associated endocrinal diseases Pregnancy, usage of contraceptive pills or steroids.

About this study

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

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

Read the detailed description

Objectives This study will be conducted to investigate the effects of Mesenchymal stem cells (MSC) transfusion on diabetic peripheral neuropathy in diabetic patient. (MSCs) have been reported to secrete various cytokines that exhibit angiogenic and neuro supportive effects.

Study Design Experimental interventional study. phase II clinical trial

Ethical committee approval (was it ethically approved by the department) Internal medicine department Yes

Study Methods

Population of study \& disease condition (e.g women with hepatitis, ………) Diabetic patients(type I, type II) with documented peripheral neuropathy as determined by impaired nerve conduction

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.

Methodology in details The study will be conducted on patients with diabetic peripheral neuropathy collected from internal medicine department(inpatient and out patients, males and females)

All subjects of this study will be submitted to the following :( preparatory visit before (MSCs) transfusion visit.)

Thorough clinical assessment as a general assessment of the patient, also assessment of diabetes complications especially diabetic neuropathy. This is including full history and examinations (e.g., pain, sensory loss, ulcers, sensory level, etc….) this preparatory assessment will be done at internal medicine department.
Venous blood will be drawn in the morning after an overnight fast in the pre (MSCs) transfusion visit.

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.
C-peptide.
Hb A1C.
Basic Fibroblast Growth Factor (bFGF), vascular endothelial growth factor (VEGF) by ELISA.
Complete blood picture.
Liver functions in the form of ALT, AST
Kidney functions in the form of serum creatinine.
fundus examination
Nerve conduction study at neurophysiology unit.
Bone marrow aspiration of about 90 ml under local anesthesia once at the first visit after preparatory visit mentioned before, the patient will be admitted for 12 hours and will be monitored closely to avoid anaphylaxis (by steroids, anti-allergic treatment), if no complication, will be discharged.

To avoid infection: During bone marrow aspiration, procedure will be done under complete aseptic precautions, placed in sterile tubes containing pre-servative-free heparin (Sigma-Aldrich, St. Louis, USA) Separation and processing of the sample will be done under good manufacture procedure (GMP): Bone Marrow Aspirate (BMA) will be withdrawn under good sterilization of the skin in an isolated area. Processing of the sample will be done in the laminar air flow; all supplies are disposable and sterile.

Technique:

Separation of mononuclear cells:

The bone marrow aspirate will be diluted at a ratio of 6:1 with phosphate buffer saline (PBS) with 2 mM EDTA (30 ml BM aspirate+ 5 ml PBS/EDTA buffer). The MNCs will be separated under aseptic conditions using a Ficoll. Hypaque desity gradient (density 1.077, GibcoBRL, Grand Islan, NY, USA) 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 370 c in a humidified atmosphere containing 5% CO2 (Digirolamo et al.1999).after one day ,non adherent cells will be cultured in the presence of Mesenchymal media for 3 weeks changed every 1 week (cambrex Bioscience ,Nottingham, uk). After reaching 80% confluence the MSCs will be placed in 10 ml saline and will be infused intravenously

Flow cytometry Surface expression of MSCs using anti- (CD271, CD34, CD73, CD90, CD105, CD29) monoclonal antibodies (mAbs) will be analyzed using flow cytometry. MSCs (2X105 cells) will be suspended in PBS containing 1% BSA and will be stained with flurochrome -conjugated mAbs for 20 minutes on ice (anti-mouse mAanti-CD 271, CD34 CD73, CD90, CD105,CD29; BD Bioscience, MN, USA).flow cytometric analysis will be performed using a FACSCaliber (BD bioscience)equipped with cell Quest software.10000 cells will be passed in front of the laser for each sample. Each sample will be analyzed in duplicate. A cut off value at 20% will be set to categorize samples as positive.

Mesenchymal stem cells will be identified by morphology and immunophenotyping in the central lab at clinical pathology department, Kasr Alaini hospital( stem cell lab).

Mesenchymal stem cells transfusion slowly intravenous will be applied after these procedures for the patients after taking their approval and informed consent.

Follow up 3 months after Mesenchymal stem cells transfusion by fasting blood glucose level, 2 hours postprandial, C-peptide, Hb A1C, (bFGF), (VEGF) and nerve conduction at kasr Alaini hospital departments as mentioned before.

Possible Risk (mention if there is any risk or not) Anaphylaxis Infection

Primary outcomes (Most important outcomes to be assessed)

1- Effect of mesenchymal stem cells transfusion on diabetic peripheral neuropathy regarding improvement of clinical symptoms like pain, sensory loss and improvement of nerve conduction.

Secondary outcome parameters (other outcomes to be assessed)

Mesenchymal stem cells being a treatment modality in diabetes complications like peripheral neuropathy, to avoid hazards on patients secondary to diabetic peripheral neuropathy.
Improving of diabetic condition like lowering of blood glucose level, decrease in insulin requirements and improvement of general condition.

Sample size (number of participants included) 10 diabetic patients with diabetic peripheral neuropathy .

Source of funding (is there any source of funds or not) Faculty Of Medicine, Cairo University.

Time plan (when to start/ when expected to finish/ when to publish) At least 20 months

Conditions: Diabetic Peripheral Neuropathy
Being tested: mesenchymal stem cells
Keywords: diabetic peripheral neuropathy, mesenchymal stem cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mesenchymal stem cellsGenetic
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

Study groups in NCT02387749
Study group	Role	What they receive
mesenchymal stem cells	Experimental	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. Receives: Genetic: mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of b-FGF, v-EGF MEASURED BY ELISA
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
Measured: zero ( before) , 7 DAYS, 90 days
Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
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
Measured: base line(zero dya), 90 days after stem cells transfusion.
Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
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
Measured: base line(zero dya), 90 days after stem cells transfusion .
Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
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
Measured: base line(zero dya), 90 days after stem cells transfusion

Secondary outcomes (2)

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, 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.
Measured: base line (zero day) and 90 days after stem cells transfusion
Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent %
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
Measured: at base line (zero day) and 90 days after stem cells transfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Dec 2016

First posted13 Mar 2015 (estimated)
Study startMay 2014
Primary completionAug 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02387749
Sponsor's protocol ID: FACULTY OF MEDICINE,CAIRO U
Status last verified: Jul 2018
First submitted: 1 Mar 2015
Last updated: 3 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Jackson L, Jones DR, Scotting P, Sottile V. Adult mesenchymal stem cells: differentiation potential and therapeutic applications. J Postgrad Med. 2007 Apr-Jun;53(2):121-7. doi: 10.4103/0022-3859.32215.
PubMed 17495381
Keilhoff G, Stang F, Goihl A, Wolf G, Fansa H. Transdifferentiated mesenchymal stem cells as alternative therapy in supporting nerve regeneration and myelination. Cell Mol Neurobiol. 2006 Oct-Nov;26(7-8):1235-52. doi: 10.1007/s10571-006-9029-9. Epub 2006 Jun 16.
PubMed 16779672
Kinnaird T, Stabile E, Burnett MS, Epstein SE. Bone-marrow-derived cells for enhancing collateral development: mechanisms, animal data, and initial clinical experiences. Circ Res. 2004 Aug 20;95(4):354-63. doi: 10.1161/01.RES.0000137878.26174.66.
PubMed 15321945
Morbach S, Lutale JK, Viswanathan V, Mollenberg J, Ochs HR, Rajashekar S, Ramachandran A, Abbas ZG. Regional differences in risk factors and clinical presentation of diabetic foot lesions. Diabet Med. 2004 Jan;21(1):91-5. doi: 10.1046/j.1464-5491.2003.01069.x.
PubMed 14706061
Nakae M, Kamiya H, Naruse K, Horio N, Ito Y, Mizubayashi R, Hamada Y, Nakashima E, Akiyama N, Kobayashi Y, Watarai A, Kimura N, Horiguchi M, Tabata Y, Oiso Y, Nakamura J. Effects of basic fibroblast growth factor on experimental diabetic neuropathy in rats. Diabetes. 2006 May;55(5):1470-7. doi: 10.2337/db05-1160.
PubMed 16644707
Rathur HM, Boulton AJ. Recent advances in the diagnosis and management of diabetic neuropathy. J Bone Joint Surg Br. 2005 Dec;87(12):1605-10. doi: 10.1302/0301-620X.87B12.16710. No abstract available.
PubMed 16326870
Shibata T, Naruse K, Kamiya H, Kozakae M, Kondo M, Yasuda Y, Nakamura N, Ota K, Tosaki T, Matsuki T, Nakashima E, Hamada Y, Oiso Y, Nakamura J. Transplantation of bone marrow-derived mesenchymal stem cells improves diabetic polyneuropathy in rats. Diabetes. 2008 Nov;57(11):3099-107. doi: 10.2337/db08-0031. Epub 2008 Aug 26.
PubMed 18728233
Adler AI, Stratton IM, Neil HA, Yudkin JS, Matthews DR, Cull CA, Wright AD, Turner RC, Holman RR. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000 Aug 12;321(7258):412-9. doi: 10.1136/bmj.321.7258.412.
PubMed 10938049
Digirolamo CM, Stokes D, Colter D, Phinney DG, Class R, Prockop DJ. Propagation and senescence of human marrow stromal cells in culture: a simple colony-forming assay identifies samples with the greatest potential to propagate and differentiate. Br J Haematol. 1999 Nov;107(2):275-81. doi: 10.1046/j.1365-2141.1999.01715.x.
PubMed 10583212
Dalla Paola L, Faglia E. Treatment of diabetic foot ulcer: an overview strategies for clinical approach. Curr Diabetes Rev. 2006 Nov;2(4):431-47. doi: 10.2174/1573399810602040431.
PubMed 18220646
Aldali F, Deng C, Nie M, Chen H. Advances in therapies using mesenchymal stem cells and their exosomes for treatment of peripheral nerve injury: state of the art and future perspectives. Neural Regen Res. 2025 Nov 1;20(11):3151-3171. doi: 10.4103/NRR.NRR-D-24-00235. Epub 2024 Oct 22.
PubMed 39435603

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

All Diabetic Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect Of Mesenchymal Stem Cells Transfusion on the Peripheral Neuropathy in Diabetic Patients Measured by Nerve Conduction.
ClinicalTrials.gov ID: NCT02387749
Acronym / sponsor ID: FACULTY OF MEDICINE,CAIRO U
Conditions: Diabetic Peripheral Neuropathy
Keywords: diabetic peripheral neuropathy, mesenchymal stem cells
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: May 2014
Primary completion: Aug 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 13 Mar 2015 (estimated)
Results: Posted 11 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design Experimental interventional study. phase II clinical trial

Ethical committee approval (was it ethically approved by the department) Internal medicine department Yes

Study Methods

Population of study \& disease condition (e.g women with hepatitis, ………) Diabetic patients(type I, type II) with documented peripheral neuropathy as determined by impaired nerve conduction

Inclusion criteria:

Exclusion criteria:

Decompensated cardiac, renal or liver disease. Associated autoimmune diseases Associated endocrinal diseases Pregnancy, usage of contraceptive pills or steroids.

Methodology in details The study will be conducted on patients with diabetic peripheral neuropathy collected from internal medicine department(inpatient and out patients, males and females)

All subjects of this study will be submitted to the following :( preparatory visit before (MSCs) transfusion visit.)

Thorough clinical assessment as a general assessment of the patient, also assessment of diabetes complications especially diabetic neuropathy. This is including full history and examinations (e.g., pain, sensory loss, ulcers, sensory level, etc….) this preparatory assessment will be done at internal medicine department.
Venous blood will be drawn in the morning after an overnight fast in the pre (MSCs) transfusion visit.

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.
C-peptide.
Hb A1C.
Basic Fibroblast Growth Factor (bFGF), vascular endothelial growth factor (VEGF) by ELISA.
Complete blood picture.
Liver functions in the form of ALT, AST
Kidney functions in the form of serum creatinine.
fundus examination
Nerve conduction study at neurophysiology unit.
Bone marrow aspiration of about 90 ml under local anesthesia once at the first visit after preparatory visit mentioned before, the patient will be admitted for 12 hours and will be monitored closely to avoid anaphylaxis (by steroids, anti-allergic treatment), if no complication, will be discharged.

Technique:

Separation of mononuclear cells:

Mesenchymal stem cells will be identified by morphology and immunophenotyping in the central lab at clinical pathology department, Kasr Alaini hospital( stem cell lab).

Mesenchymal stem cells transfusion slowly intravenous will be applied after these procedures for the patients after taking their approval and informed consent.

Possible Risk (mention if there is any risk or not) Anaphylaxis Infection

Primary outcomes (Most important outcomes to be assessed)

1- Effect of mesenchymal stem cells transfusion on diabetic peripheral neuropathy regarding improvement of clinical symptoms like pain, sensory loss and improvement of nerve conduction.

Secondary outcome parameters (other outcomes to be assessed)

Mesenchymal stem cells being a treatment modality in diabetes complications like peripheral neuropathy, to avoid hazards on patients secondary to diabetic peripheral neuropathy.
Improving of diabetic condition like lowering of blood glucose level, decrease in insulin requirements and improvement of general condition.

Sample size (number of participants included) 10 diabetic patients with diabetic peripheral neuropathy .

Source of funding (is there any source of funds or not) Faculty Of Medicine, Cairo University.

Time plan (when to start/ when expected to finish/ when to publish) At least 20 months

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
mesenchymal stem cells	Experimental	Genetic: mesenchymal stem cellsThe 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.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

(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.

Key exclusion criteria (1 listed)

Decompensated cardiac, renal or liver disease. Associated autoimmune diseases Associated endocrinal diseases Pregnancy, usage of contraceptive pills or steroids.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mesenchymal stem cellscollection 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	Genetic	mesenchymal stem cells

Primary outcome

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

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 11 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy	10	10

Primary outcome: Measurement of b-FGF, v-EGF MEASURED BY ELISA

Time frame: zero ( before) , 7 DAYS, 90 days. Mean (Standard Deviation). Unit: pg/ml

Measure	Measurement of b-FGF and v- EGF MEASURED BY ELISA n = 10
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)

Measurement of b-FGF and v- EGF MEASURED BY ELISA: p = 0.005, Chi-squared, Corrected

Population analysed: 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

Primary outcome: 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.. Mean (Standard Deviation). Unit: m/sec

Measure	Nerve Conduction Velocities of Nerves n = 10
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)

Primary outcome: 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 .. Mean (Standard Deviation). Unit: msec

Measure	Nerve Conduction Latency of Nerves n = 10
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)

Primary outcome: 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. Mean (Standard Deviation). Unit: uv

Measure	Nerve Conduction Amplitudes of Nerves n = 10
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)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17495381Jackson L, Jones DR, Scotting P, Sottile V. Adult mesenchymal stem cells: differentiation potential and therapeutic applications. J Postgrad Med. 2007 Apr-Jun;53(2):121-7. doi: 10.4103/0022-3859.32215.
Background: PubMed 16779672Keilhoff G, Stang F, Goihl A, Wolf G, Fansa H. Transdifferentiated mesenchymal stem cells as alternative therapy in supporting nerve regeneration and myelination. Cell Mol Neurobiol. 2006 Oct-Nov;26(7-8):1235-52. doi: 10.1007/s10571-006-9029-9. Epub 2006 Jun 16.
Background: PubMed 15321945Kinnaird T, Stabile E, Burnett MS, Epstein SE. Bone-marrow-derived cells for enhancing collateral development: mechanisms, animal data, and initial clinical experiences. Circ Res. 2004 Aug 20;95(4):354-63. doi: 10.1161/01.RES.0000137878.26174.66.
Background: PubMed 14706061Morbach S, Lutale JK, Viswanathan V, Mollenberg J, Ochs HR, Rajashekar S, Ramachandran A, Abbas ZG. Regional differences in risk factors and clinical presentation of diabetic foot lesions. Diabet Med. 2004 Jan;21(1):91-5. doi: 10.1046/j.1464-5491.2003.01069.x.
Background: PubMed 16644707Nakae M, Kamiya H, Naruse K, Horio N, Ito Y, Mizubayashi R, Hamada Y, Nakashima E, Akiyama N, Kobayashi Y, Watarai A, Kimura N, Horiguchi M, Tabata Y, Oiso Y, Nakamura J. Effects of basic fibroblast growth factor on experimental diabetic neuropathy in rats. Diabetes. 2006 May;55(5):1470-7. doi: 10.2337/db05-1160.
Background: PubMed 16326870Rathur HM, Boulton AJ. Recent advances in the diagnosis and management of diabetic neuropathy. J Bone Joint Surg Br. 2005 Dec;87(12):1605-10. doi: 10.1302/0301-620X.87B12.16710. No abstract available.
Background: PubMed 18728233Shibata T, Naruse K, Kamiya H, Kozakae M, Kondo M, Yasuda Y, Nakamura N, Ota K, Tosaki T, Matsuki T, Nakashima E, Hamada Y, Oiso Y, Nakamura J. Transplantation of bone marrow-derived mesenchymal stem cells improves diabetic polyneuropathy in rats. Diabetes. 2008 Nov;57(11):3099-107. doi: 10.2337/db08-0031. Epub 2008 Aug 26.
Background: PubMed 10938049Adler AI, Stratton IM, Neil HA, Yudkin JS, Matthews DR, Cull CA, Wright AD, Turner RC, Holman RR. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000 Aug 12;321(7258):412-9. doi: 10.1136/bmj.321.7258.412.
Background: PubMed 10583212Digirolamo CM, Stokes D, Colter D, Phinney DG, Class R, Prockop DJ. Propagation and senescence of human marrow stromal cells in culture: a simple colony-forming assay identifies samples with the greatest potential to propagate and differentiate. Br J Haematol. 1999 Nov;107(2):275-81. doi: 10.1046/j.1365-2141.1999.01715.x.
Background: PubMed 18220646Dalla Paola L, Faglia E. Treatment of diabetic foot ulcer: an overview strategies for clinical approach. Curr Diabetes Rev. 2006 Nov;2(4):431-47. doi: 10.2174/1573399810602040431.
Derived from this study: PubMed 39435603Aldali F, Deng C, Nie M, Chen H. Advances in therapies using mesenchymal stem cells and their exosomes for treatment of peripheral nerve injury: state of the art and future perspectives. Neural Regen Res. 2025 Nov 1;20(11):3151-3171. doi: 10.4103/NRR.NRR-D-24-00235. Epub 2024 Oct 22.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamed Gamal ElDin Saadi, phd study chair

Cairo University

Dina Abdelmagid, MD, MRCP UK principal investigator

Cairo University

Questions about this trial

What is this clinical trial studying?

A study testing mesenchymal stem cells in people with Diabetic Peripheral Neuropathy, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of b-FGF, v-EGF MEASURED BY ELISA (time frame: zero ( before) , 7 DAYS, 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02387749, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.