Clinical trial of the evaluation of the effect of intracavernous stem cell injection on the treatment of erectile dysfunction compared to control group in diabetic patients
Evaluation of the Effect of Intracavernous Stem Cell Injection on the Treatment of Erectile Dysfunction in Diabetic Patients Referring to Kerman Diabetes Clinic in 2019
Design
Clinical trial with control group, with parallel groups, single blind, block randomization
Settings and conduct
In the intervention group, with local anesthesia, a tissue sample of about half a centimeter diameter without the need for suturing from the oral mucosa of each person was taken and immediately sent to the center of the stem cells of the Kerman University of Medical Sciences. In the intervention group, a 1 cc stem cell is injected into each corpus cavernosome, and in the normal control group, 1 cc is injected into both corpus cavernosomes. Patients are not aware of the type of injectable(single blind). Patients are followed up with International Index of Erectile Function (IIEF5) questionnaire and Doppler doppler sonography, Fasting Blood Sugar (FBS) and Glycated hemoglobin (HBA1C) within three months and six months after injection. In addition, morning erection is recorded by patients every day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetes, sexual dysfunction, BMI 20-25 and Ages: 55-75 years.
Exclusion criteria: Laboratory disorders (low testosterone and high prolactin and high fasting blood glucose and impaired lipids and ...)
Heart disease
Other diseases leading to erectile dysfunction
Intervention groups
In the intervention group, a tissue sample is taken from the oral mucosa of each person and sent to the center of the stem cell. The cells collected in the intervention group are injected into each corpus cavernosome of one cent. In the normal control group,1 cc of saline is injected into both corpus cavernosomes.
Main outcome variables
Improving erectile function in patients
Complications of injection (pain, swelling and ecchymosis)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190517043609N1
Registration date:2020-01-25, 1398/11/05
Registration timing:registered_while_recruiting
Last update:2020-01-25, 1398/11/05
Update count:0
Registration date
2020-01-25, 1398/11/05
Registrant information
Name
mohammadali bagherinasabsarab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3222 1600
Email address
ma_bagherinasab_md@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the evaluation of the effect of intracavernous stem cell injection on the treatment of erectile dysfunction compared to control group in diabetic patients
Public title
Evaluation of the effect of intracavernous stem cell injection on the treatment of erectile dysfunction in diabetic patients
In this study, the block randomization method is used. Thus, of the 4 blocks, each block consisting of 2 intervention groups and 2 control groups, with the aim of progressing smoothly over the time of the groups, and this method continued until the sample size was completed 20 (including 10 Intervention group and 10 control group or 5 blocks of 4).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the primary researcher (physician and data collector) is aware of the type of injectable material, but patients are unaware of the type of injectable material and are kept blind. Patients were divided into two groups of 10 intervention and control groups who were injected randomized with stem cell or normal saline.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Havaniroz Street ,Ghadir Street
City
Kerman
Province
Kerman
Postal code
7618113908
Approval date
2019-10-13, 1398/07/21
Ethics committee reference number
115.IR.KMU.AH.REC.1398
Health conditions studied
1
Description of health condition studied
Erectile dysfunction
ICD-10 code
N52
ICD-10 code description
Male erectile dysfunction
Primary outcomes
1
Description
Erectile function
Timepoint
3 and 6 months after the injection
Method of measurement
Questionnaire IIEF5 (International Index of Erectile Dysfunction Inventory) and Patient Statement and Color Doppler Sonography
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: In the intervention group with local anesthesia, a tissue sample of about half a centimeter diameter without any need for suture was taken from each patient's oral mucosa and inserted into a solution of phosphate buffer containing antibiotics and amphotripsin (Exir Nano Sina co.) and immediately sent to the University's Stem Cell Center. Mucosal tissue transmitted 3 times with antibiotic buffered phosphate buffer and amphotripsin, divided into small parts under sterile conditions and at 4 ° C for 24 hours, adjacent to DMEM (Dulbeccos Modified Eagle Medium) (Neda Shimi Co.) medium containing 4 mg / mL of dysphasic enzyme and 3 mg / mL collagenase type 1 is placed. After 24 hours, the enzymum is slowly released and placed in a DMEM medium containing 15% FBS and 1% antibiotic (penicillin / streptomycin) (Exir Nano Sina co.) in a CO2 incubator (5%) with a humidity of 95% and a temperature of 37 °.After sticking and growing cells, which lasts for at least about 10 days, the adherent cells of the adipose trypsin enzyme are cultured again in the T25 flask after separation. Finally, the cells were examined for stem cell markers and purity by fluocytometric method and if th purity was more than 95%, the cells collected to be injected into the patient should be kept in the physician. After taking the required amount of stem cells (60-50 million), the sample is sent to the Freeze room to the urological room and after melting with normal saline 0.9% diluted (up to 2 cc), into the intervention group in each corpus cavernosome is injected 1 cc. Then all patients in the intervention group follow by the International Index of Erectile Function (IIEF5) questionnaire and Doppler Sonography, Fasting Blood Sugar (FBS), and Glycated Hemoglobin (HBA1C) within three months and six months after injection. In addition, morning erection is recorded by patients every day.
Category
Treatment - Drugs
2
Description
Control group: In control group, 1 cc normal saline is injected in each Corpus cavernosum .Then all patients in the control group follow by the IIEF5 questionnaire and Doppler Sonography, FBS, and HBA1C within three months and six months after injection. In addition, morning erection is recorded by patients every day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Kerman Diabetes
Full name of responsible person
Mahbobe Mirzaie
Street address
Qaraney street, Bahonar hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3222 1600
Email
ma_baghernasab_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Beginning of the axis of Alavi Campus Campus, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahbobe Mirzaie
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
St. Qarani Hospital Bahonar
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3222 1600
Email
mirzaeimahboubeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahbobe Mirzaie
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
St. Qarani Hospital Bahonar
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3222 1600
Email
mirzaeimahboubeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Ali Bagherinasabsarab
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Qaraney Street, Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3222 1600
Email
ma_baghernasab_md@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available