Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
NCT ID: NCT02745808
Last Updated: 2019-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2015-09-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HUC-MSCs
Intracavernous injection of 15 million HUC-MSCs.
HUC-MSCs
The subjects will receive intracavernous injection of HUCMSC.
Injectable Collagen Scaffold + HUC-MSCs
Intracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs.
Injectable Collagen Scaffold + HUC-MSCs
The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.
Interventions
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HUC-MSCs
The subjects will receive intracavernous injection of HUCMSC.
Injectable Collagen Scaffold + HUC-MSCs
The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
65 Years
MALE
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Principal Investigators
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Jianwu Dai, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Sciences
Locations
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAS-XDA-DEF/IGDB
Identifier Type: -
Identifier Source: org_study_id
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