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

Chinese Academy of Sciences1 site in 1 country34 target enrollmentJanuary 2016

ConditionsRectal Cancer Erectile Dysfunction

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Rectal Cancer
Sponsor: Chinese Academy of Sciences
Enrollment: 34
Locations: 1
Primary Endpoint: Safety and Tolerability assessed by Adverse Events
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

December 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Chinese Academy of Sciences

Responsible Party

Principal Investigator

Jianwu Dai

Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Chinese Academy of Sciences

Eligibility Criteria

Inclusion Criteria

•Diagnosed with local rectal cancer, which is within 12cm from anus.
•Male, 20-65 years old.
•IIEF-5 score\>
•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.

Outcomes

Primary Outcomes

Safety and Tolerability assessed by Adverse Events

Time Frame: Up to 6 months

Secondary Outcomes

Nocturnal penile tumescence (NPT)(1, 3, 6, 12 months)
Maximum Flow Rate (Qmax)(1, 3, 6, 12 months)
IIEF-5 (International Index of Erectile Function)(1, 3, 6, 12 months)
Penile cavernosal artery peak systolic velocity (PSV)(1, 3, 6, 12 months)
Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3(1, 3, 6, 12 months)
The change of results of Nerve electrophysiological examination(1, 3, 6, 12 months)