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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer treatment. The purpose of this study is to assess the safety and efficacy of autologous bone marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) combined with NeuroRegen scaffold transplantation in men with erectile dysfunction after rectal cancer treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic surgery | Sham Comparator | Patients receive no interventions after rectal cancer treatment. |
|
| NeuroRegen scaffold transplantation | Experimental | Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment. |
|
| NeuroRegen scaffold/BMMCs transplantation | Experimental | Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment. |
|
| NeuroRegen scaffold/HUC-MSCs transplantation | Experimental | Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic surgery | Procedure | Completely resected rectal tumor. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability assessed by Adverse Events | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| IIEF-5 (International Index of Erectile Function) | Improvements in sexual function based on the (IIEF)-5 questionnaire | 1, 3, 6, 12 months |
| Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yutian Dai, M.D. | Contact | 86-25-83106666 | 70502 | 13913957628@163.com |
| Sufang Han, Ph.D. | Contact | 86-10-82614420 | sufanghan22@genetics.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianwu Dai, Ph.D. | Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| NeuroRegen scaffold transplantation |
| Device |
After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve. |
|
| NeuroRegen scaffold/BMMCs transplantation | Biological | Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million bone marrow mononuclear cells to the nerve. |
|
| NeuroRegen scaffold/HUC-MSCs transplantation | Biological | Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million human umbilical cord mesenchymal cells to the nerve. |
|
Changes in mean scores of Sexual Encounter Profile (SEP) Question 2 and 3 will be evaluated and reported.
| 1, 3, 6, 12 months |
| Penile cavernosal artery peak systolic velocity (PSV) | Changes in penile cavernosal artery peak systolic velocity in [cm/s] as determined by Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection. | 1, 3, 6, 12 months |
| Nocturnal penile tumescence (NPT) | Monitor penis erection during sleep to assess erection function of the patients. | 1, 3, 6, 12 months |
| The change of results of Nerve electrophysiological examination | To assess the penile sensory pathway abnormalities of the patients with or without premature ejaculation. | 1, 3, 6, 12 months |
| Maximum Flow Rate (Qmax) | Change of the maximum flow rate (Qmax) to assess the bladder function. | 1, 3, 6, 12 months |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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