Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes

Last updated: January 23, 2019
Sponsor: Chinese Academy of Sciences
Overall Status: Active - Recruiting

Phase

1

Condition

Impotence

Male Hormonal Deficiencies/abnormalities

Infertility

Treatment

N/A

Clinical Study ID

NCT02745808
CAS-XDA-DEF/IGDB
  • Ages 20-65
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 twiceper 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 sexualencounters.

Exclusion

Exclusion Criteria:

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

  2. Positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis CVirus (HCV) syphilis test

  3. Testosterone level is less than 200ng/dL

  4. Serum AST/ALT >3upper limit of normal or creatinine >1.5upper limit of normal

  5. HbA1c exhibit greater than 10%

  6. In the investigators judgment, with clinical significance of penis abnormalities, orhas 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 entryor enrolled in a concurrent study that may confound results of this study

  9. Unwilling and/or not able to give written informed consent

Study Design

Total Participants: 30
Study Start date:
September 01, 2015
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

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