UMIN-CTR Clinical Trial

Basic information
Public title	Single intracavernous injection of autologous adipose-derived stem cells versus a single high dose of Platelet Rich Plasma to improve erectile dysfunction: A comparative study
Acronym	SICIADSCVSSIPRPTEDCS
Scientific Title	Single intracavernous injection of autologous adipose-derived stem cells versus a single high dose of Platelet Rich Plasma to improve erectile dysfunction
Scientific Title:Acronym	SICIADSCVSSIPRPTED
Region	Asia(except Japan)

Condition
Condition	Erectile dysfunction
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	compare the efficacy and safety of single high dose PRP intracavernous injection and single dose of Adipose mesenchymal Stem Cells (ADSC) in patients with severe ED.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	effectiveness of single high dose PRP intracavernous injection and single dose of Adipose mesenchymal Stem Cells (ADSC) in patients with severe ED.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Adipose mesenchymal Stem Cells (ADSC) Single dose Intracavernous injections
Interventions/Control_2	Platelet rich plasma (PRP) Single dose Intracavernous injections
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	60 years-old <=
Age-upper limit	70 years-old >=
Gender	Male
Key inclusion criteria	male with severe ED refractory to conventional therapies
Key exclusion criteria	male with mild to moderate ED
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Mohamad Middle name Last name Abou Chakra
Organization	Al Zahraa Hospital-Stem cell institute
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, Stem Cell institute
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	009611850040ext3365
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	2022 Year 11 Month 02 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	20
Results
Results date posted
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	2019 Year 08 Month 17 Day
Date of IRB	2020 Year 01 Month 20 Day
Anticipated trial start date	2020 Year 01 Month 25 Day
Last follow-up date	2022 Year 08 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 11 Month 02 Day
Last modified on	2022 Year 11 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056247