UMIN-CTR Clinical Trial

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
Email	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
Email	mohamadamoussa@hotmail.com

Sponsor
Institute	Al Zahraa Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049204