Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Erectile Dysfunction
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|ClinicalTrials.gov Identifier: NCT02344849|
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Drug: mesenchymal stem cell||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open, Single-center, Phase 1 Study to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction.|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||April 2018|
Experimental: Mesenchymal stem cell
Patients will receive single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take on demand.
Drug: mesenchymal stem cell
Patients will receive single injection of Cellgram-ED( 30,000,000 mesenchymal stem cell) intracavernously.
Other Name: Cellgram-ED
- Number and severity of adverse events [ Time Frame: 12month ]Analyze the laboratory, vital sign, physical exam results from baseline to end of the study for investigate adverse reactions and view safety.
- Change From Baseline in the International Index of Erectile Function(IIEF) [ Time Frame: month 1, 3, 6, 9 and 12 ]Description of the average variation from the screening value in each group using the Student's preordered t-test (Wilcoxon's signed bank test).
- Penile Duplex Ultrasonography [ Time Frame: month 6, 12 ]Change From Baseline in Peak systolic velocity (PSV) and End diastolic velocity (EDV)
- Change From Baseline in Sexual Encounter Profile (SEP) Question 2 [ Time Frame: month 1, 3, 6, 9 and 12 ]The SEP2 survey describes cumulative success rates for 30 days, 3 months, 6 months, 9 months and 12 months after cell treatment.
- Global Assessment Question (GAQ) [ Time Frame: month 1, 3, 6, 9 and 12 ]The GAQ survey describes cumulative success rates for 30 days, 3 months, 6 months, 9 months and 12 months after cell treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344849
|Korea, Republic of|
|Asan medical center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Chungsu Kim, Ph.D||AIDS Malignancy Consortium|