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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

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 7, 2016
Last Update Posted Date January 25, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
Safety and Tolerability assessed by Adverse Events [ Time Frame: Up to 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02648386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
  • IIEF-5 (International Index of Erectile Function) [ Time Frame: 1, 3, 6, 12 months ]
    Improvements in sexual function based on the (IIEF)-5 questionnaire
  • 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.
  • 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.
  • Nocturnal penile tumescence (NPT) [ Time Frame: 1, 3, 6, 12 months ]
    Monitor penis erection during sleep to assess erection function of the patients.
  • 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.
  • Maximum Flow Rate (Qmax) [ Time Frame: 1, 3, 6, 12 months ]
    Change of the maximum flow rate (Qmax) to assess the bladder function.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Therapy Combined With NeuroRegen Scaffold™ in Patients With Erectile Dysfunction After Rectal Cancer Surgery
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rectal Cancer
  • Erectile Dysfunction
Intervention  ICMJE
  • Procedure: Laparoscopic surgery
    Completely resected rectal tumor.
  • Device: NeuroRegen scaffold transplantation
    After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.
  • 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.
  • 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.
Study Arms  ICMJE
  • Sham Comparator: Laparoscopic surgery
    Patients receive no interventions after rectal cancer treatment.
    Intervention: Procedure: Laparoscopic surgery
  • Experimental: NeuroRegen scaffold transplantation
    Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.
    Intervention: Device: NeuroRegen scaffold transplantation
  • Experimental: NeuroRegen scaffold/BMMCs transplantation
    Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
    Intervention: Biological: NeuroRegen scaffold/BMMCs transplantation
  • Experimental: NeuroRegen scaffold/HUC-MSCs transplantation
    Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
    Intervention: Biological: NeuroRegen scaffold/HUC-MSCs transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2016)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02648386
Other Study ID Numbers  ICMJE CAS-XDA-ED-IGDB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianwu Dai, Chinese Academy of Sciences
Study Sponsor  ICMJE Chinese Academy of Sciences
Collaborators  ICMJE The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators  ICMJE
Principal Investigator: Jianwu Dai, Ph.D. Chinese Academy of Sciences
PRS Account Chinese Academy of Sciences
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP