A clinical trial of the treatment of Erectile Dysfunction (ED) by using of adipose derived mesenchymal stem cells (MSCs)
Design
A clinical trial with two groups of patients: parallel, therapeutic, simple random, single blind (researcher).100 patients referred to Sinai Hospital.
Settings and conduct
100 patients at Sina Hospital. blanced block randomization, single blind(researcher).Patients are divided into two groups. After completing the written consent, In one group, 5 million adipose-derived mesenchymal stem cells are injected in three times, and in the other group, 10 million cells are injected.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Mental health/Do not take psychiatric drugs/Age range 18-70 years/No possibility of damage to the main pelvic arteries/Reluctance to change the penis prosthesis/Tendency to perform stem cell injection therapy
Exclusion criteria:Patients with cardiovascular disease/Underlying diseases
Psychiatric problems or addiction/Failure to follow the patient at the appointed times/Deactivation of sexual life/neurologic or hormonal Erectile dysfunction/lack of sexual interest
Intervention groups
Intervention Group1: Adipose is removed from a specific area of the patient's thigh or abdomen with a simple surgery, then the patient's adipose derived mesenchymal stem cells are separated and processed under appropriate conditions and injected into the patient (5 million cells in three injections).
Intervention Group2: Adipose is removed from a specific area of the patient's thigh or abdomen with a simple surgery, then the patient's adipose derived mesenchymal stem cells are separated and processed under appropriate conditions and injected into the patient (10 million cells in three injections).
Main outcome variables
Improving the quality of patients' erections,
Increase patient satisfaction,
Patients' desire for sex,
Effectiveness time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N11
Registration date:2020-11-27, 1399/09/07
Registration timing:registered_while_recruiting
Last update:2020-11-27, 1399/09/07
Update count:0
Registration date
2020-11-27, 1399/09/07
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of the treatment of Erectile Dysfunction (ED) by using of adipose derived mesenchymal stem cells (MSCs)
Public title
Evaluation of Mesenchymal Stem Cell transplantation (MSCS) in the treatment of Erectile Dysfunction (ED)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mental Health
Do not take psychiatric drugs
Age range 18-70 years
No possibility of damage to the main pelvic arteries
Reluctance to change the penis prosthesis
Tendency to perform stem cell injection therapy
Exclusion criteria:
Patients with Cardiovascular disease
Underlying diseases
Psychiatric problems or Addiction
Failure to follow the patient at the appointed times
Deactivation of Sexual Life
Neurologic or Hormonal Erectile Dysfunction
Lack of Sexual Interest
Age
From 18 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a single-blind randomized clinical trial.
For randomization, the blanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined.According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned.
After the methodologist prepares the randomization sequence using the sealdenvelop online site, the generated sequence will be made available to a technician outside the research team.Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician.The patient is placed in (5 million cells in three injections) or (10 million cells in three injections) group based on the randomly selected envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher has no information about the surgical procedure and the design. Surgery is performed by various surgeons during the week, and finally, the coded results are delivered to the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee for Research in Tehran University of Medical Sciences
Street address
Room 604, Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-09-10, 1399/06/20
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.438
Health conditions studied
1
Description of health condition studied
Erectile Dysfunction
ICD-10 code
N52.9
ICD-10 code description
Male erectile dysfunction, unspecified
Primary outcomes
1
Description
Improve erectile quality
Timepoint
One month, two months, three months, six months and one year after adipose derived mesenchymal stem cells injection
Method of measurement
Record of Peak systolic velocity (PSV) and end diastolic velocity (EDV) and complete the International Index of Erectile Function (IIEF-5) questionnaire and perform color Doppler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Adipose is removed from a specific area of the patient's thigh or abdomen with a simple surgery, then the patient's adipose derived mesenchymal stem cells are separated and processed under appropriate conditions and injected into the patient (5 million cells in three injections)(One month, two months and three months after the intervention, the same number of cells are injected into the patient).
Category
Treatment - Surgery
2
Description
Intervention group: Adipose is removed from a specific area of the patient's thigh or abdomen with a simple surgery, then the patient's adipose derived mesenchymal stem cells are separated and processed under appropriate conditions and injected into the patient (10 million cells in three injections)(One month, two months and three months after the intervention, the same number of cells are injected into the patient).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Seyed Mohammad Kazem Aghamir Mohammadali
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St., Tehran, Iran.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
demographic information anonymously
When the data will become available and for how long
one year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.