NCT02745808

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 25, 2019

Status Verified

April 1, 2016

Enrollment Period

5.3 years

First QC Date

April 12, 2016

Last Update Submit

January 23, 2019

Conditions

Erectile DysfunctionType 1 Diabetes MellitusType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability assessed by Adverse Events

    1 month after intervention

Secondary Outcomes (2)

  • Improvement in IIEF-5 (International Index of Erectile Function)

    1,3,6,9 and 12 months

  • Improvement in penile colour Doppler ultrasonography

    1,3,6,9 and 12 months

Study Arms (2)

HUC-MSCs

EXPERIMENTAL

Intracavernous injection of 15 million HUC-MSCs.

Biological: HUC-MSCs

Injectable Collagen Scaffold + HUC-MSCs

EXPERIMENTAL

Intracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs.

Biological: Injectable Collagen Scaffold + HUC-MSCs

Interventions

HUC-MSCsBIOLOGICAL

The subjects will receive intracavernous injection of HUCMSC.

HUC-MSCs
Injectable Collagen Scaffold + HUC-MSCsBIOLOGICAL

The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.

Injectable Collagen Scaffold + HUC-MSCs

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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): 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
  • HbA1c is between 6.5%-10%
  • Physical examination with no abnormalities
  • Willing to consent to participate in the study follow-up
  • Willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Erectile DysfunctionDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jianwu Dai, Ph.D

    Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhifeng Xiao, Ph.D

CONTACT

86-10-82614420zfxiao@genetics.ac.cn

Sufang Han, Ph.D

CONTACT

86-10-82614420sufanghan22@genetics.ac.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 20, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 25, 2019

Record last verified: 2016-04

Locations

CN(1)