Erectile Dysfunction, Rectal Cancer
Conditions
Brief summary
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.
Interventions
PROCEDURELaparoscopic surgery
Completely resected rectal tumor.
DEVICENeuroRegen scaffold transplantation
After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.
BIOLOGICALNeuroRegen scaffold/BMMCs transplantation
Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million bone marrow mononuclear cells to the nerve.
BIOLOGICALNeuroRegen scaffold/HUC-MSCs transplantation
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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with local rectal cancer, which is within 12cm from anus. 2. Male, 20-65 years old. 3. IIEF-5 score\> 21. 4. No obvious abnormal in external genitalia, testis, epididymis and spermatic cord. 5. Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study. 6. Signed informed consent. 7. Recently take no drugs affecting sexual function (such as androgen replacement drugs, PDE5i and Chinese patent medicine, etc.).
Exclusion criteria
1. Suffering hypertension or diabetes. 2. In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery. 3. Patient's partner is trying to conceive during the trial period. 4. Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. 5. Geographically inaccessible for follow-up visits required by protocol or want to other treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability assessed by Adverse Events | Up to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3 | 1, 3, 6, 12 months | Changes in mean scores of Sexual Encounter Profile (SEP) Question 2 and 3 will be evaluated and reported. |
| Penile cavernosal artery peak systolic velocity (PSV) | 1, 3, 6, 12 months | Changes in penile cavernosal artery peak systolic velocity in \[cm/s\] as determined by Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection. |
| IIEF-5 (International Index of Erectile Function) | 1, 3, 6, 12 months | Improvements in sexual function based on the (IIEF)-5 questionnaire |
| The change of results of Nerve electrophysiological examination | 1, 3, 6, 12 months | To assess the penile sensory pathway abnormalities of the patients with or without premature ejaculation. |
| Maximum Flow Rate (Qmax) | 1, 3, 6, 12 months | Change of the maximum flow rate (Qmax) to assess the bladder function. |
| Nocturnal penile tumescence (NPT) | 1, 3, 6, 12 months | Monitor penis erection during sleep to assess erection function of the patients. |
Countries
China
Contacts
Primary ContactYutian Dai, M.D.
Backup ContactSufang Han, Ph.D.
Outcome results
None listed