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

Study Overview
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Brief Summary
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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.

Official Title
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Bone Marrow Mononuclear Cells or Human Umbilical Cord-derived Mesenchymal Stem Cells Combined With NeuroRegen Scaffold™ Transplantation for the Improvement of Erectile Function in Men After Rectal Cancer Surgery

Conditions
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Rectal Cancer, Erectile Dysfunction

Intervention / Treatment
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* Procedure: Laparoscopic surgery
* Device: NeuroRegen scaffold transplantation
* Biological: NeuroRegen scaffold/BMMCs transplantation
* Biological: NeuroRegen scaffold/HUC-MSCs transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with local rectal cancer, which is within 12cm from anus. Male, 20-65 years old. IIEF-5 score> 21. No obvious abnormal in external genitalia, testis, epididymis and spermatic cord. Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study. Signed informed consent. Recently take no drugs affecting sexual function (such as androgen replacement drugs, PDE5i and Chinese patent medicine, etc.). Exclusion Criteria: Suffering hypertension or diabetes. In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery. Patient's partner is trying to conceive during the trial period. 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. Geographically inaccessible for follow-up visits required by protocol or want to other treatment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Laparoscopic surgery<br>Patients receive no interventions after rectal cancer treatment. | Procedure: Laparoscopic surgery<br>* Completely resected rectal tumor.<br>|
| Experimental: NeuroRegen scaffold transplantation<br>Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment. | Device: NeuroRegen scaffold transplantation<br>* After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.<br>|
| Experimental: NeuroRegen scaffold/BMMCs transplantation<br>Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment. | Biological: NeuroRegen scaffold/BMMCs transplantation<br>* Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million bone marrow mononuclear cells to the nerve.<br>|
| Experimental: NeuroRegen scaffold/HUC-MSCs transplantation<br>Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment. | Biological: NeuroRegen scaffold/HUC-MSCs transplantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability assessed by Adverse Events |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |