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Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes

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ClinicalTrials.gov Identifier: NCT02745808
Recruitment Status : Recruiting
First Posted : April 20, 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 April 12, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date January 25, 2019
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Safety and Tolerability assessed by Adverse Events [ Time Frame: 1 month after intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02745808 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
  • Improvement in IIEF-5 (International Index of Erectile Function) [ Time Frame: 1,3,6,9 and 12 months ]
    The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function
  • Improvement in penile colour Doppler ultrasonography [ Time Frame: 1,3,6,9 and 12 months ]
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 Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
Official Title  ICMJE Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) for the Improvement of Erectile Function in Men With Diabetes
Brief Summary The intent of this clinical study is to answer the questions: 1) is the proposed treatment feasible; 2) is treatment effective in improving the disease pathology of patients with diagnosed diabetic erectile dysfunction.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Erectile Dysfunction
  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Biological: HUC-MSCs
    The subjects will receive intracavernous injection of HUCMSC.
  • Biological: Injectable Collagen Scaffold + HUC-MSCs
    The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.
Study Arms  ICMJE
  • Experimental: HUC-MSCs
    Intracavernous injection of 15 million HUC-MSCs.
    Intervention: Biological: HUC-MSCs
  • Experimental: Injectable Collagen Scaffold + HUC-MSCs
    Intracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs.
    Intervention: Biological: Injectable Collagen Scaffold + HUC-MSCs
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: April 18, 2016)
30
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. Type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i
  2. Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study
  3. Males, age 20-65 years
  4. IIEF-5 score is under 16
  5. Penile arterial insufficiency or venous leakage (doppler): peak systolic velocity(PSV) <25 cm/sec, or peak systolic velocity(PSV)>25 cm/sec, end-diastolic velocity(EDV)> 5cm/sec, resistance index(RI)<0.75
  6. HbA1c is between 6.5%-10%
  7. Physical examination with no abnormalities
  8. Willing to consent to participate in the study follow-up
  9. Willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.

Exclusion Criteria:

  1. Severe cardiovascular disease (angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy
  2. Positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) syphilis test
  3. Testosterone level is less than 200ng/dL
  4. Serum AST/ALT >3*upper limit of normal or creatinine >1.5*upper limit of normal
  5. HbA1c exhibit greater than 10%
  6. In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery
  7. Patients partner is trying to conceive during the trial period
  8. 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
  9. Unwilling and/or not able to give written informed consent
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: Zhifeng Xiao, Ph.D 86-10-82614420 zfxiao@genetics.ac.cn
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 NCT02745808
Other Study ID Numbers  ICMJE CAS-XDA-DEF/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 April 2016

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