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Status unknownNCT02745808Updated Jan 25, 2019

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

A Phase 1 interventional study of HUC-MSCs and Injectable Collagen Scaffold + HUC-MSCs in Erectile Dysfunction, Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, sponsored by Chinese Academy of Sciences. Status unknown at 1 site in China. Open to male participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by Chinese Academy of Sciences · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Male
01

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.

02

Conditions studied

  • Erectile Dysfunction
  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
03

In context

Erectile Dysfunction

682 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Chinese Academy of Sciences is the lead sponsor of 65 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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): 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 sexual encounters.

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    HUC-MSCs

    Intracavernous injection of 15 million HUC-MSCs.

    Biological: HUC-MSCs

  • Experimental
    Injectable Collagen Scaffold + HUC-MSCs

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

    Biological: Injectable Collagen Scaffold + HUC-MSCs

Interventions

  • BiologicalHUC-MSCs

    The subjects will receive intracavernous injection of HUCMSC.

  • BiologicalInjectable Collagen Scaffold + HUC-MSCs

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

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability assessed by Adverse Events

    Time frame: 1 month after intervention

Secondary outcomes

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

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

    Time frame: 1,3,6,9 and 12 months

  2. Improvement in penile colour Doppler ultrasonography

    Time frame: 1,3,6,9 and 12 months

07

Study locations

1 of 1 sites recruiting
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210008, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02745808
Lead sponsor
Chinese Academy of Sciences
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Jianwu Dai (Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences) — Principal investigator
First posted
Apr 20, 2016
Start date
Sep 2015
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jan 25, 2019

Study contacts

Zhifeng Xiao, Ph.D
Contact
zfxiao@genetics.ac.cn
86-10-82614420
Sufang Han, Ph.D
Contact
sufanghan22@genetics.ac.cn
86-10-82614420
Jianwu Dai, Ph.D
principal investigator · Chinese Academy of Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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