Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Erectile Dysfunction
|ClinicalTrials.gov Identifier: NCT02344849|
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 9, 2019
|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.
An SAE suggests a significant hazard, contraindication, side-effect, or precaution. With respect to human clinical experience, this includes any event that:
Results in death. Is life-threatening.* Requires in-patient hospitalization or prolongation of existing hospitalization.
Results in persistent or significant disability/incapacity. Is a congenital anomaly/birth defect. Other medically important condition
Life-threatening in the definition of a SAE or adverse reaction refers to an event in which the patient was at risk of death at the time of event; it does not refer to an event, which hypothetically might have caused death if it were more severe.
- 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).
- Erectile Function (Q1,2,3,4,5,15) : Min 6 ~ Max 30
- Orgasmic Function (Q9,10) : Min 2 ~ Max 10
- Sexual Desire (Q11,12) : : Min 2 ~ Max 10
- Intercourse Satisfaction (Q6,7,8): : Min 3 ~ Max 15
- Overall Satisfaction (Q13,14) : Min 2 ~ Max 10
- Penile Doppler Sonography, PDS [ Time Frame: month 6, 12 ]
Change From Baseline in Peak systolic velocity (PSV) and End diastolic velocity (EDV), Evaluate Erection rigidity During the test.
The normal maximum systolic blood flow of the cavernosal artery after injection of vasodilators is 30 cm / s or more.
- PDS results are obtained 5 min, 10 min, 15 min, 20 min, 25 min and 30 min after intracavernosal injection.
The peak systolic velocity (PSV) is assessed as follows:
>25 cm/s is considered to be normal, 20-25 cm/s is considered to be mild ED, 12-20 cm/s is considered to be moderate ED, <12 cm/s is considered to be severe arteriogenic impotence.
The end diastolic velocity (EDV) is assessed as follows:
- 5 cm/s is considered to be a normal value, >5 cm/s is considered to indicate a veno-occlusive disorder.
- 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.
SEP 2 Were you able to insert your penis into your partner's vagina? Yes or No SEP 3 Did your erection last long enough to have successful intercourse? Yes or No
- 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.
- Did Cellgram-ED improve your Erectile Function? Yes or No
- If so, did Cellgram-ED improve the ability to have sex? Yes or No
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|