Erectile DysfunctionPhase 1NCT02745808
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
A Phase 1 study testing HUC-MSCs and Injectable Collagen Scaffold + HUC-MSCs in people with Erectile Dysfunction and Type 1 Diabetes Mellitus, run by Chinese Academy of Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- HUC-MSCs and Injectable Collagen Scaffold + HUC-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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): 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
- HbA1c is between 6.5%-10%
Show all 9Show fewer
- Physical examination with no abnormalities
- Willing to consent to participate in the study follow-up
- Willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Yutian Dai, M.D., 86-25-83106666 ext. 70502, 13913957628@163.com
LeiLei Zhu, M.D., 86-25-83106666 ext. 70502, zhuleilei68n@163.com
About this study
Official title: Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) 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.
- Being tested
- HUC-MSCs, Injectable Collagen Scaffold + HUC-MSCs
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUC-MSCsBiological
The subjects will receive intracavernous injection of HUCMSC.
Injectable Collagen Scaffold + HUC-MSCsBiological
The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.
| Study group | Role | What they receive |
|---|---|---|
| HUC-MSCs | Experimental | Intracavernous injection of 15 million HUC-MSCs. Receives: Biological: HUC-MSCs |
| Injectable Collagen Scaffold + HUC-MSCs | Experimental | Intracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs. Receives: Biological: Injectable Collagen Scaffold + HUC-MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability assessed by Adverse Events
Measured: 1 month after intervention
Secondary outcomes (2)
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
Measured: 1,3,6,9 and 12 months
Improvement in penile colour Doppler ultrasonography
Measured: 1,3,6,9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jianwu Dai, Chinese Academy of Sciences
- Investigators
- Jianwu Dai, Ph.D, Principal investigator, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745808
- Sponsor's protocol ID
- CAS-XDA-DEF/IGDB
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) for the Improvement of Erectile Function in Men With Diabetes
- ClinicalTrials.gov ID
- NCT02745808
- Acronym / sponsor ID
- CAS-XDA-DEF/IGDB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- Sep 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HUC-MSCs | Experimental | Biological: HUC-MSCsIntracavernous injection of 15 million HUC-MSCs. |
| Injectable Collagen Scaffold + HUC-MSCs | Experimental | Biological: Injectable Collagen Scaffold + HUC-MSCsIntracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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): 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
Key exclusion criteria (9 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUC-MSCsThe subjects will receive intracavernous injection of HUCMSC. | Biological | HUC-MSCs |
| Injectable Collagen Scaffold + HUC-MSCsThe subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs. | Biological | Injectable Collagen Scaffold + HUC-MSCs |
Primary outcome
Safety and Tolerability assessed by Adverse Events
Time frame: 1 month after intervention
2 secondary outcomes
Improvement in IIEF-5 (International Index of Erectile Function)
Time frame: 1,3,6,9 and 12 months
Improvement in penile colour Doppler ultrasonography
Time frame: 1,3,6,9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianwu Dai, Ph.D principal investigator
Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HUC-MSCs and Injectable Collagen Scaffold + HUC-MSCs in people with Erectile Dysfunction and Type 1 Diabetes Mellitus, run by Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhifeng Xiao, Ph.D (86-10-82614420, zfxiao@genetics.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability assessed by Adverse Events (time frame: 1 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.