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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cell | Experimental | Patients will receive single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take on demand. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cell | Drug | Patients will receive single injection of Cellgram-ED( 30,000,000 mesenchymal stem cell) intracavernously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12month |
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
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Inclusion Criteria:
Postprostatectomy Erectile Dysfunction
Diabetes-associated Erectile Dysfunction
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chungsu Kim, Ph.D | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan medical center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34326007 | Derived | You D, Jang MJ, Song G, Shin HC, Suh N, Kim YM, Ahn TY, Kim CS. Safety of autologous bone marrow-derived mesenchymal stem cells in erectile dysfunction: an open-label phase 1 clinical trial. Cytotherapy. 2021 Oct;23(10):931-938. doi: 10.1016/j.jcyt.2021.06.001. Epub 2021 Jul 27. |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| 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.
| 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 | 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
| month 1, 3, 6, 9 and 12 |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |