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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Completely resected rectal tumor.
After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.
Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million bone marrow mononuclear cells to the nerve.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGSafety and Tolerability assessed by Adverse Events
Time frame: Up to 6 months
IIEF-5 (International Index of Erectile Function)
Improvements in sexual function based on the (IIEF)-5 questionnaire
Time frame: 1, 3, 6, 12 months
Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3
Changes in mean scores of Sexual Encounter Profile (SEP) Question 2 and 3 will be evaluated and reported.
Time frame: 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.
Time frame: 1, 3, 6, 12 months
Nocturnal penile tumescence (NPT)
Monitor penis erection during sleep to assess erection function of the patients.
Time frame: 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.
Time frame: 1, 3, 6, 12 months
Maximum Flow Rate (Qmax)
Change of the maximum flow rate (Qmax) to assess the bladder function.
Time frame: 1, 3, 6, 12 months
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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.