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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049204


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name