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

NCT02648386 | Unknown Phase 1 DMC

• 1 other identifier: CAS-XDA-ED-IGDB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability assessed by Adverse Events

  Up to 6 months

Secondary Outcomes (6)

• IIEF-5 (International Index of Erectile Function)

  1, 3, 6, 12 months

• Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3

  1, 3, 6, 12 months

• Penile cavernosal artery peak systolic velocity (PSV)

  1, 3, 6, 12 months

• Nocturnal penile tumescence (NPT)

  1, 3, 6, 12 months

• The change of results of Nerve electrophysiological examination

  1, 3, 6, 12 months

Study Arms (4)

Laparoscopic surgery

SHAM COMPARATOR

Patients receive no interventions after rectal cancer treatment.

Procedure: Laparoscopic surgery

NeuroRegen scaffold transplantation

EXPERIMENTAL

Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.

Device: NeuroRegen scaffold transplantation

NeuroRegen scaffold/BMMCs transplantation

EXPERIMENTAL

Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment.

Biological: NeuroRegen scaffold/BMMCs transplantation

NeuroRegen scaffold/HUC-MSCs transplantation

EXPERIMENTAL

Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment.

Biological: NeuroRegen scaffold/HUC-MSCs transplantation

Interventions

Laparoscopic surgery PROCEDURE

Completely resected rectal tumor.

Laparoscopic surgery

NeuroRegen scaffold transplantation DEVICE

After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.

NeuroRegen scaffold transplantation

NeuroRegen scaffold/BMMCs transplantation BIOLOGICAL

Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million bone marrow mononuclear cells to the nerve.

NeuroRegen scaffold/BMMCs transplantation

NeuroRegen scaffold/HUC-MSCs transplantation BIOLOGICAL

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.

NeuroRegen scaffold/HUC-MSCs transplantation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Erectile Dysfunction

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jianwu Dai, Ph.D.

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yutian Dai, M.D.

CONTACT

86-25-83106666; 13913957628@163.com

Sufang Han, Ph.D.

CONTACT

86-10-82614420; sufanghan22@genetics.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 7, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 25, 2019

Record last verified: 2015-12

Locations

CN (1)