UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050898 |
|---|---|
| Receipt number | R000058006 |
| Scientific Title | Single intracavernous injection of autologous adipose-derived stem cells for post radical prostatectomy erectile dysfunction |
| Date of disclosure of the study information | 2023/04/20 |
| Last modified on | 2023/04/20 22:31:27 |
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Basic information
Public title
Efficacy and safety of a single intracavernous injection of autologous adipose-derived stem cells for post radical prostatectomy erectile dysfunction
Acronym
ESSIPRPED
Scientific Title
Single intracavernous injection of autologous adipose-derived stem cells for post radical prostatectomy erectile dysfunction
Scientific Title:Acronym
SIPRPED
Region
| Asia(except Japan) |
Condition
Condition
Erectile Dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the efficacy of intracavernous adipose stem cells (ADSC)in the treatment of ED post RP
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Erectile function (EF) was tested using the IIEF-5 score after intracorporal injection of ADSCs
Key secondary outcomes
Assess safety of ADSC therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treatment group receiving a single intracavernous injection of ADSC post RP and kept on PDE5i
Interventions/Control_2
Patients received only PDE5i
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
| 58 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
Males operated by RP with the none-nerve sparing technique.
All patients were potent before RP.
The same urologist performed the RPs.
Key exclusion criteria
Impotent males before RP
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Mohamad |
| Middle name | |
| Last name | Moussa |
Organization
Al Zahraa Hospital,Beirut, Lebanon
Division name
Urology
Zip code
1108
Address
Beirut, Lebanon
TEL
+9613964412
mohamadamoussa@hotmail.com
Public contact
Name of contact person
| 1st name | Mohamad |
| Middle name | |
| Last name | Abou Chakra |
Organization
Al Zahraa Hospital
Division name
Urology
Zip code
1108
Address
Beirut, Lebanon
TEL
+96171613732
Homepage URL
mohamadabouchakra@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
009611851040ext3364
uroprog@gmail
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
| 2023 | Year | 04 | Month | 20 | 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
14
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 6 and 12 months, in this group, the degree of ED was moderate in 3 patients and mild in 4 patients. In the control group, for patients treated only with PDE5i, the ED remains severe all the time
No significant side effects were reported by the patients after ADSCs injections
Results date posted
| 2023 | Year | 04 | Month | 20 | 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
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 26 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058006
