Collagen Scaffolds Loaded With HUCMSCs for the Improvemen... | NCT02579148

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

NCT02579148

Sponsor

Leilei Zhu

Status

Withdrawn

Last Update Posted

Apr 8, 2016Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Erectile Dysfunction
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus

Interventions

HUCMSC injection
collagen scaffolds/HUCMSC injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Oct 14, 2015

First Submission Date that Met QC Criteria

Oct 16, 2015

First Posted Date

Oct 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2016

Last Update Posted Date

Apr 8, 2016Estimated

Name	Class
Chinese Academy of Sciences	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
HUCMSC injection	Biological	The subjects will receive intracavernous injection of HUCMSC.'	HUCMSC injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jianwu Dai	Chinese Academy of Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Drum Tower Hospital		Nanjing	Jiangsu	210000	China

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided