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

January 23, 2019 updated by: Jianwu Dai, Chinese Academy of Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Laparoscopic surgery
Patients receive no interventions after rectal cancer treatment.
Procedure: Laparoscopic surgery
Completely resected rectal tumor.
EXPERIMENTAL: NeuroRegen scaffold transplantation
Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.
Device: NeuroRegen scaffold transplantation
After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.
EXPERIMENTAL: NeuroRegen scaffold/BMMCs transplantation
Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
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.
EXPERIMENTAL: NeuroRegen scaffold/HUC-MSCs transplantation
Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability assessed by Adverse Events
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IIEF-5 (International Index of Erectile Function)
Time Frame: 1, 3, 6, 12 months
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
Time Frame: 1, 3, 6, 12 months
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)
Time Frame: 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.
1, 3, 6, 12 months
Nocturnal penile tumescence (NPT)
Time Frame: 1, 3, 6, 12 months
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
Time Frame: 1, 3, 6, 12 months
To assess the penile sensory pathway abnormalities of the patients with or without premature ejaculation.
1, 3, 6, 12 months
Maximum Flow Rate (Qmax)
Time Frame: 1, 3, 6, 12 months
Change of the maximum flow rate (Qmax) to assess the bladder function.
1, 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Sciences

Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (ESTIMATE)

January 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAS-XDA-ED-IGDB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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