NCT02648386

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Chinese Academy of Sciences · Other Government
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Erectile Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic surgery	Completely resected rectal tumor.
DEVICE	NeuroRegen scaffold transplantation	After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.
BIOLOGICAL	NeuroRegen 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.
BIOLOGICAL	NeuroRegen 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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2016-01-07
• Last updated: 2019-01-25

Locations

1 site across 1 country: China