NCT02579148

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

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 8, 2016

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

October 14, 2015

Last Update Submit

April 7, 2016

Conditions

Erectile DysfunctionType 1 Diabetes MellitusType 2 Diabetes Mellitus

Keywords

erectile dysfunctionstem cellcollagen scaffold

Outcome Measures

Primary Outcomes (1)

  • Improvements in IIEF scores

    The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function.

    1,3,6,9 and 12 months

Secondary Outcomes (2)

  • Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection

    1,3,6,9 and 12 months

  • Safety and Tolerability assessed by Adverse Events

    1 month after intervention

Study Arms (2)

HUCMSC injection

EXPERIMENTAL

once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells

Biological: HUCMSC injection

collagen scaffolds/HUCMSC injection

EXPERIMENTAL

once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells

Biological: collagen scaffolds/HUCMSC injection

Interventions

HUCMSC injectionBIOLOGICAL

The subjects will receive intracavernous injection of HUCMSC.'

HUCMSC injection
collagen scaffolds/HUCMSC injectionBIOLOGICAL

The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'

collagen scaffolds/HUCMSC injection

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): 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.

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)

Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

Location

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

    Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
science and technology department head

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 19, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

April 8, 2016

Record last verified: 2015-10

Locations

CN(1)