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

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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Recruitment Status : Withdrawn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

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: HUCMSC injection Biological: collagen scaffolds/HUCMSC injection Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells for the Improvement of Erectile Function in Men With Diabetes
Study Start Date : September 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: HUCMSC injection
once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
Biological: HUCMSC injection
The subjects will receive intracavernous injection of HUCMSC.`

Experimental: collagen scaffolds/HUCMSC injection
once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
Biological: collagen scaffolds/HUCMSC injection
The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.`




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection [ Time Frame: 1,3,6,9 and 12 months ]
  2. Safety and Tolerability assessed by Adverse Events [ Time Frame: 1 month after intervention ]


Information from the National Library of Medicine

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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): 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.

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): NCT02579148


Locations
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China, Jiangsu
Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Leilei Zhu
Chinese Academy of Sciences
Investigators
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Principal Investigator: Jianwu Dai Chinese Academy of Sciences

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Responsible Party: Leilei Zhu, science and technology department head, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT02579148     History of Changes
Other Study ID Numbers: DTH-922-DYT
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: October 2015
Keywords provided by Leilei Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
erectile dysfunction
stem cell
collagen scaffold
Additional relevant MeSH terms:
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Erectile Dysfunction
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders