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Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02579148
Recruitment Status : Withdrawn
First Posted : October 19, 2015
Last Update Posted : April 8, 2016
Sponsor:
Collaborator:
Chinese Academy of Sciences
Information provided by (Responsible Party):
Leilei Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE October 19, 2015
Last Update Posted Date April 8, 2016
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2015)
Improvements in IIEF scores [ 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02579148 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2015)
  • Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection [ Time Frame: 1,3,6,9 and 12 months ]
  • Safety and Tolerability assessed by Adverse Events [ Time Frame: 1 month after intervention ]
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 Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
Official Title  ICMJE Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells 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 Intracavernous transplantation of stem cells has been shown to improve erectile function in some preclinical studies. However, inadequate cell homing to damaged sites limited its functions. The investigators explore the effect of HUCMSC on improving erectile function of diabetic men, and whether collagen scaffolds contribute to long-term cell retention in the corpus cavernous and improves erectile function of diabetic men.
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: HUCMSC injection
    The subjects will receive intracavernous injection of HUCMSC.`
  • Biological: collagen scaffolds/HUCMSC injection
    The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.`
Study Arms  ICMJE
  • Experimental: HUCMSC injection
    once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
    Intervention: Biological: HUCMSC injection
  • Experimental: collagen scaffolds/HUCMSC injection
    once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
    Intervention: Biological: collagen scaffolds/HUCMSC injection
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 5, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2015)
20
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date December 2016   (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): PSV <25 cm/sec, or PSV >25 cm/sec, EDV>5cm/sec, RI<0, 75;
  6. HbA1c is between 6.5% 10%;
  7. physical examination with no abnormalities;
  8. who is 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02579148
Other Study ID Numbers  ICMJE DTH-922-DYT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leilei Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sponsor  ICMJE Leilei Zhu
Collaborators  ICMJE Chinese Academy of Sciences
Investigators  ICMJE
Principal Investigator: Jianwu Dai Chinese Academy of Sciences
PRS Account The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Verification Date October 2015

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