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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

blood pressure all patients were normal blood pressure measurement

routine lab investigations were normal to exclude other co-morbidites


Reporting Groups
  Description
Mesenchymal Stem Cells Transfusion in DPN Patients This study was conducted on 10 patients with Diabetic peripheral neuropathy (DPN), 4 females and 6 males

Baseline Measures
   Mesenchymal Stem Cells Transfusion in DPN Patients 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.20  (4.59) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  40.0% 
Male      6  60.0% 
Region of Enrollment 
[Units: Participants]
 
Egypt   10 


  Outcome Measures

1.  Primary:   Measurement of b-FGF, v-EGF MEASURED BY ELISA   [ Time Frame: zero ( before) , 7 DAYS, 90 days ]

2.  Primary:   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. ]

3.  Primary:   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 . ]

4.  Primary:   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 ]

5.  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   [ Time Frame: base line (zero day) and 90 days after stem cells transfusion ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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


  More Information

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
e-mail: drdina_m@hotmail.com


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