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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 : Unknown
Verified April 2016 by Jianwu Dai, Chinese Academy of Sciences.
Recruitment status was:  Recruiting
First Posted : April 20, 2016
Last Update Posted : February 15, 2018
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:
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Biological: HUC-MSCs Biological: Injectable Collagen Scaffold + HUC-MSCs Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) for the Improvement of Erectile Function in Men With Diabetes
Study Start Date : September 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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Arm Intervention/treatment
Experimental: HUC-MSCs
Intracavernous injection of 15 million HUC-MSCs.
 Biological: HUC-MSCs
The subjects will receive intracavernous injection of HUCMSC.
Experimental: Injectable Collagen Scaffold + HUC-MSCs
Intracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs.
 Biological: Injectable Collagen Scaffold + HUC-MSCs
The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability assessed by Adverse Events [ Time Frame: 1 month after intervention ]

Secondary Outcome Measures :
  1. 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

  2. Improvement in penile colour Doppler ultrasonography [ Time Frame: 1,3,6,9 and 12 months ]

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. 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
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): NCT02745808


Contacts
Contact: Zhifeng Xiao, Ph.D 86-10-82614420 zfxiao@genetics.ac.cn
Contact: Sufang Han, Ph.D 86-10-82614420 sufanghan22@genetics.ac.cn

Locations
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
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: NCT02745808     History of Changes
Other Study ID Numbers: CAS-XDA-DEF/IGDB
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: April 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Erectile Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders