Back to resultsCollagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
Primary Purpose
Erectile Dysfunction, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HUCMSC injection
collagen scaffolds/HUCMSC injection
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring erectile dysfunction, stem cell, collagen scaffold
Eligibility Criteria
Inclusion Criteria:
- type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i;
- have a consistent partner who is willing to engage in sexual activity more than twice per month during the study;
- males age 20-65 years;
- IIEF-5 score is under 16;
- penile arterial insufficiency or venous leakage (doppler): PSV <25 cm/sec, or PSV >25 cm/sec, EDV>5cm/sec, RI<0, 75;
- HbA1c is between 6.5% 10%;
- physical examination with no abnormalities;
- who is willing to consent to participate in the study follow-up;
- willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.
Exclusion Criteria:
- severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy;
- positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) syphilis test;
- Testosterone level is less than 200ng/dl;
- serum AST/ALT >3*upper limit of normal or creatinine >1.5*upper limit of normal;
- HbA1c exhibit greater than 10%;
- in the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery;
- patients partner is trying to conceive during the trial period;
- 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;
- unwilling and/or not able to give written informed consent.
Sites / Locations
- Drum Tower Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HUCMSC injection
collagen scaffolds/HUCMSC injection
Arm Description
once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
Outcomes
Primary Outcome Measures
Improvements in IIEF scores
The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function.
Secondary Outcome Measures
Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection
Safety and Tolerability assessed by Adverse Events
Full Information
NCT ID
NCT02579148
First Posted
October 14, 2015
Last Updated
April 7, 2016
Sponsor
Leilei Zhu
Collaborators
Chinese Academy of Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02579148
Brief Title
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
Official Title
Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells for the Improvement of Erectile Function in Men With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leilei Zhu
Collaborators
Chinese Academy of Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Keywords
erectile dysfunction, stem cell, collagen scaffold
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HUCMSC injection
Arm Type
Experimental
Arm Description
once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
Arm Title
collagen scaffolds/HUCMSC injection
Arm Type
Experimental
Arm Description
once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
Intervention Type
Biological
Intervention Name(s)
HUCMSC injection
Intervention Description
The subjects will receive intracavernous injection of HUCMSC.'
Intervention Type
Biological
Intervention Name(s)
collagen scaffolds/HUCMSC injection
Intervention Description
The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'
Primary Outcome Measure Information:
Title
Improvements in IIEF scores
Description
The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function.
Time Frame
1,3,6,9 and 12 months
Secondary Outcome Measure Information:
Title
Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection
Time Frame
1,3,6,9 and 12 months
Title
Safety and Tolerability assessed by Adverse Events
Time Frame
1 month after intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i;
have a consistent partner who is willing to engage in sexual activity more than twice per month during the study;
males age 20-65 years;
IIEF-5 score is under 16;
penile arterial insufficiency or venous leakage (doppler): PSV <25 cm/sec, or PSV >25 cm/sec, EDV>5cm/sec, RI<0, 75;
HbA1c is between 6.5% 10%;
physical examination with no abnormalities;
who is willing to consent to participate in the study follow-up;
willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.
Exclusion Criteria:
severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy;
positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) syphilis test;
Testosterone level is less than 200ng/dl;
serum AST/ALT >3*upper limit of normal or creatinine >1.5*upper limit of normal;
HbA1c exhibit greater than 10%;
in the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery;
patients partner is trying to conceive during the trial period;
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;
unwilling and/or not able to give written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianwu Dai
Organizational Affiliation
Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
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