This phase I clinical trial is designed to evaluate the safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.
Cellgram-ED is autologous bone marrow-derived mesenchymal stem cells ex vivo expanded for approximately 30 days. Ten patients (Diabetes -associated ED; 5 patients, Postprostatectomy; 5patients) will be injected Cellgram-ED directly into the intracavernous. Patient will be evaluated the safety and potential efficacy of MSC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will receive single injection of Cellgram-ED( 30,000,000 mesenchymal stem cell) intracavernously.
Asan medical center
Seoul, South Korea
Number and severity of adverse events
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.
Time frame: 12month
Change From Baseline in the International Index of Erectile Function(IIEF)
Description of the average variation from the screening value in each group using the Student's preordered t-test (Wilcoxon's signed bank test). Function domain * 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: month 1, 3, 6, 9 and 12
Penile Doppler Sonography, PDS
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. 1. PDS results are obtained 5 min, 10 min, 15 min, 20 min, 25 min and 30 min after intracavernosal injection. 2. 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. 3. 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.
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Time frame: month 6, 12
Change From Baseline in Sexual Encounter Profile (SEP) Question 2
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
Time frame: month 1, 3, 6, 9 and 12
Global Assessment Question (GAQ)
The GAQ survey describes cumulative success rates for 30 days, 3 months, 6 months, 9 months and 12 months after cell treatment. GAQ 1. Did Cellgram-ED improve your Erectile Function? Yes or No 2. If so, did Cellgram-ED improve the ability to have sex? Yes or No
Time frame: month 1, 3, 6, 9 and 12