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

April 7, 2016 updated by: Leilei Zhu

Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells for the Improvement of Erectile Function in Men With Diabetes

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Drum Tower Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i;
  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): PSV <25 cm/sec, or PSV >25 cm/sec, EDV>5cm/sec, RI<0, 75;
  6. HbA1c is between 6.5% 10%;
  7. physical examination with no abnormalities;
  8. who is 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:

  1. severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy;
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HUCMSC injection
once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
Biological: HUCMSC injection
The subjects will receive intracavernous injection of HUCMSC.'
Experimental: collagen scaffolds/HUCMSC injection
once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
Biological: collagen scaffolds/HUCMSC injection
The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements in IIEF scores
Time Frame: 1,3,6,9 and 12 months
The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function.
1,3,6,9 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability assessed by Adverse Events
Time Frame: 1 month after intervention
1 month after intervention
Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection
Time Frame: 1,3,6,9 and 12 months
1,3,6,9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leilei Zhu

Collaborators

Chinese Academy of Sciences

Investigators

  • Principal Investigator: Jianwu Dai, Chinese Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTH-922-DYT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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