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

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ClinicalTrials.gov Identifier: NCT02648386
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Erectile Dysfunction Procedure: Laparoscopic surgery Device: NeuroRegen scaffold transplantation Biological: NeuroRegen scaffold/BMMCs transplantation Biological: NeuroRegen scaffold/HUC-MSCs transplantation Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability assessed by Adverse Events [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. IIEF-5 (International Index of Erectile Function) [ Time Frame: 1, 3, 6, 12 months ]
    Improvements in sexual function based on the (IIEF)-5 questionnaire

  2. 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.

  3. 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.

  4. Nocturnal penile tumescence (NPT) [ Time Frame: 1, 3, 6, 12 months ]
    Monitor penis erection during sleep to assess erection function of the patients.

  5. 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.

  6. Maximum Flow Rate (Qmax) [ Time Frame: 1, 3, 6, 12 months ]
    Change of the maximum flow rate (Qmax) to assess the bladder function.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648386


Contacts
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Contact: Yutian Dai, M.D. 86-25-83106666 ext 70502 13913957628@163.com
Contact: Sufang Han, Ph.D. 86-10-82614420 sufanghan22@genetics.ac.cn

Locations
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China, Jiangsu
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Yutian Dai, M.D.    86-25-83106666 ext 70502    13913957628@163.com   
Contact: LeiLei Zhu, M.D.    86-25-83106666 ext 70502    zhuleilei68n@163.com   
Sponsors and Collaborators
Chinese Academy of Sciences
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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Principal Investigator: Jianwu Dai, Ph.D. Chinese Academy of Sciences
More Information
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Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02648386    
Other Study ID Numbers: CAS-XDA-ED-IGDB
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: December 2015
Additional relevant MeSH terms:
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Rectal Neoplasms
Erectile Dysfunction
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders