UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043103 |
|---|---|
| Receipt number | R000049204 |
| Scientific Title | The effect of a single intracavernous injection of autologous adipose-derived stem cells in patients with erectile dysfunction following radical cystectomy |
| Date of disclosure of the study information | 2021/01/22 |
| Last modified on | 2021/01/22 22:26:07 |
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Basic information
Public title
The effect of a single intracavernous injection of autologous adipose-derived stem cells in patients with erectile dysfunction
Acronym
IIADSC
Scientific Title
The effect of a single intracavernous injection of autologous adipose-derived stem cells in patients with erectile dysfunction following radical cystectomy
Scientific Title:Acronym
EIIADSC
Region
| Asia(except Japan) |
Condition
Condition
Erectile dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of intracavernous adipose stem cells(ADSC) and their effect on erectile dysfunction for patients operated by radical cystectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assess the erectile function of the study groups: the control group and the treatment group
Assess the safety of adipose stem cell in the treatment group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Singleintracavernous Adipose stem cell injection+ phosphodiesterase 5 inhibitors (tadalafil 5mg daily)
Interventions/Control_2
phosphodiesterase 5 inhibitors (tadalafil 5mg daily)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 55 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Potent male before radical cystectomy
Patients with severe erectile dysfunction when entering the study
Key exclusion criteria
Impotent male before radical cystectomy
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Mohamad |
| Middle name | Walid |
| Last name | Abou Chakra |
Organization
Al zahraa hospital
Division name
Urology
Zip code
1108
Address
Beirut, Lebanon
TEL
0096171613732
mohamedabouchakra@hotmail.com
Public contact
Name of contact person
| 1st name | Mohamad |
| Middle name | |
| Last name | Moussa |
Organization
Al Zahraa Hospital
Division name
Urology
Zip code
1108
Address
Beirut, Lebanon
TEL
009613964412
Homepage URL
mohamadamoussa@hotmail.com
Sponsor or person
Institute
Al Zahraa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Al Zahraa Hospital
Address
Beirut, Lebanon
Tel
009611851040
IRB-zahraa@outlook.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Following ADSCs administration, the EF was improved in all patients of the treatment group. One month after therapy, All of the patients in the treatment group had an increase in their IEF-5 score. At 3 and 6 months, in this group, the degree of ED was mild in all patients. In the control group, for patients treated only with PDE5i, the ED remains severe all the time
Results date posted
| 2021 | Year | 01 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 19 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 23 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049204
