This phase II clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.
To evaluate the efficacy and efficacy for 12 months after a single dose of Cellgram-ED in patients with erectile dysfunction after radical prostatectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
Patients will receive single injection of Cellgram-ED(mesenchymal stem cell) intracavernously.
Asan medical center
Seoul, South Korea
Ewha womans university medical center
Seoul, South Korea
Samsung medical center
Seoul, South Korea
Seoul ST. Mary's hospital
Seoul, South Korea
The amount of change in EF score in the International Erectile Function Questionnaire (IIEF) at administration of the clinical trial drug compared to the baseline value
Descriptive statistics for the amount of change at administration of the investigational drug compared to the baseline value for each administration group are presented and analyzed by an analysis of covariance (ANCOVA) 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
Time frame: 6 month
The amount of change in EF score in the International Erectile Function Questionnaire (IIEF) at administration of the clinical trial drug compared to the baseline value
Descriptive statistics for the amount of change at administration of the investigational drug compared to the baseline value for each administration group are presented and analyzed by an analysis of covariance (ANCOVA) Erectile Function (Q1,2,3,4,5,15) : Min 6 \~ Max 30
Time frame: month 1, 3, 6, 9 and 12
Changes in SEP Q 2 and Q 3 evaluation after administration of investigational drug compared to baseline
Descriptive statistics for the success rate change at each time point and baseline value for each administration group are presented and analyzed by covariance analysis (ANCOVA) 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
Time frame: month 1, 3, 6, 9 and 12
Global Assessment Question (GAQ) evaluation after administration of investigational drugs
The frequency and percentage of each time point by administration group are presented and analyzed by Pearson's chi-square test or Fisher's exact test Did Cellgram-ED improve your Erectile Function? Yes or No If so, did Cellgram-ED improve the ability to have sex? Yes or No
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Time frame: month 1, 3, 6, 9 and 12
Changes in Penile Doppler Sonography(PDS) level after administration of clinical trial drug compared to baseline
For the continuous variable, descriptive statistics for each time point in each administration group and the change at each time point compared to the baseline value are presented, and analyzed by covariance analysis (ANCOVA) 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.
Time frame: month 6, 12