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

Primary Purpose

Rectal Cancer, Erectile Dysfunction

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Laparoscopic surgery

NeuroRegen scaffold transplantation

NeuroRegen scaffold/BMMCs transplantation

NeuroRegen scaffold/HUC-MSCs transplantation

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Arm Label

Laparoscopic surgery

NeuroRegen scaffold transplantation

NeuroRegen scaffold/BMMCs transplantation

NeuroRegen scaffold/HUC-MSCs transplantation

Arm Description

Patients receive no interventions after rectal cancer treatment.

Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.

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

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

Outcomes

Primary Outcome Measures

Safety and Tolerability assessed by Adverse Events

Secondary Outcome Measures

IIEF-5 (International Index of Erectile Function)

Improvements in sexual function based on the (IIEF)-5 questionnaire

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.

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.

Nocturnal penile tumescence (NPT)

Monitor penis erection during sleep to assess erection function of the patients.

The change of results of Nerve electrophysiological examination

To assess the penile sensory pathway abnormalities of the patients with or without premature ejaculation.

Maximum Flow Rate (Qmax)

Change of the maximum flow rate (Qmax) to assess the bladder function.

Full Information

NCT ID

NCT02648386

First Posted

January 5, 2016

Last Updated

January 23, 2019

Sponsor

Chinese Academy of Sciences

Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

1. Study Identification

Unique Protocol Identification Number

NCT02648386

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Sciences

Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer, Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic surgery

Arm Type

Sham Comparator

Arm Description

Patients receive no interventions after rectal cancer treatment.

Arm Title

NeuroRegen scaffold transplantation

Arm Type

Experimental

Arm Description

Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.

Arm Title

NeuroRegen scaffold/BMMCs transplantation

Arm Type

Experimental

Arm Description

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

Arm Title

NeuroRegen scaffold/HUC-MSCs transplantation

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic surgery

Intervention Description

Completely resected rectal tumor.

Intervention Type

Device

Intervention Name(s)

NeuroRegen scaffold transplantation

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

NeuroRegen scaffold/BMMCs transplantation

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

NeuroRegen scaffold/HUC-MSCs transplantation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety and Tolerability assessed by Adverse Events

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

IIEF-5 (International Index of Erectile Function)

Description

Improvements in sexual function based on the (IIEF)-5 questionnaire

Time Frame

1, 3, 6, 12 months

Title

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

Description

Changes in mean scores of Sexual Encounter Profile (SEP) Question 2 and 3 will be evaluated and reported.

Time Frame

1, 3, 6, 12 months

Title

Penile cavernosal artery peak systolic velocity (PSV)

Description

Changes in penile cavernosal artery peak systolic velocity in [cm/s] as determined by Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection.

Time Frame

1, 3, 6, 12 months

Title

Nocturnal penile tumescence (NPT)

Description

Monitor penis erection during sleep to assess erection function of the patients.

Time Frame

1, 3, 6, 12 months

Title

The change of results of Nerve electrophysiological examination

Description

To assess the penile sensory pathway abnormalities of the patients with or without premature ejaculation.

Time Frame

1, 3, 6, 12 months

Title

Maximum Flow Rate (Qmax)

Description

Change of the maximum flow rate (Qmax) to assess the bladder function.

Time Frame

1, 3, 6, 12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yutian Dai, M.D.

Phone

86-25-83106666

Ext

70502

13913957628@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sufang Han, Ph.D.

Phone

86-10-82614420

sufanghan22@genetics.ac.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianwu Dai, Ph.D.

Organizational Affiliation

Chinese Academy of Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yutian Dai, M.D.

Phone

86-25-83106666

Ext

70502

13913957628@163.com

First Name & Middle Initial & Last Name & Degree

LeiLei Zhu, M.D.

Phone

86-25-83106666

Ext

70502

zhuleilei68n@163.com

12. IPD Sharing Statement

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

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