Stem Cell Therapy Combined With NeuroRegen Scaffold™ in Patients With Erectile Dysfunction After Rectal Cancer Surgery

Phase 1

• Conditions: Rectal Cancer; Erectile Dysfunction
• Interventions: Procedure: Laparoscopic surgery; Device: NeuroRegen scaffold transplantation; Biological: NeuroRegen scaffold/BMMCs transplantation; Biological: NeuroRegen scaffold/HUC-MSCs transplantation

• Registration Number: NCT02648386
• Lead Sponsor: Chinese Academy of Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-12
• Study Start: 2016-01
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-25
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic surgery	Laparoscopic surgery	Patients receive no interventions after rectal cancer treatment.
NeuroRegen scaffold transplantation	NeuroRegen scaffold transplantation	Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.
NeuroRegen scaffold/BMMCs transplantation	NeuroRegen scaffold/BMMCs transplantation	Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
NeuroRegen scaffold/HUC-MSCs transplantation	NeuroRegen scaffold/HUC-MSCs transplantation	Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability assessed by Adverse Events	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
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.
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.
IIEF-5 (International Index of Erectile Function)	1, 3, 6, 12 months	Improvements in sexual function based on the (IIEF)-5 questionnaire
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.
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.

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China