Erectile DysfunctionPhase 1NCT02579148
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
A Phase 1 study testing HUCMSC injection and collagen scaffolds/HUCMSC injection in people with Erectile Dysfunction and Type 1 Diabetes Mellitus, run by Leilei Zhu 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?
- HUCMSC injection and collagen scaffolds/HUCMSC injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Apr 2017
- 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): PSV <25 cm/sec, or PSV >25 cm/sec, EDV>5cm/sec, RI<0, 75;
- HbA1c is between 6.5% 10%;
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- 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.
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;
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- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- HUCMSC injection, collagen scaffolds/HUCMSC injection
- Keywords
- erectile dysfunction, stem cell, collagen scaffold
- 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.
HUCMSC injectionBiological
The subjects will receive intracavernous injection of HUCMSC.'
collagen scaffolds/HUCMSC injectionBiological
The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'
| Study group | Role | What they receive |
|---|---|---|
| HUCMSC injection | Experimental | once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells Receives: 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 Receives: Biological: collagen scaffolds/HUCMSC injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in IIEF scores
The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function.
Measured: 1,3,6,9 and 12 months
Secondary outcomes (2)
Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection
Measured: 1,3,6,9 and 12 months
Safety and Tolerability assessed by Adverse Events
Measured: 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leilei Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor-investigator, Leilei Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Jianwu Dai, Principal investigator, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579148
- Sponsor's protocol ID
- DTH-922-DYT
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells for the Improvement of Erectile Function in Men With Diabetes
- ClinicalTrials.gov ID
- NCT02579148
- Acronym / sponsor ID
- DTH-922-DYT
- Keywords
- erectile dysfunction, stem cell, collagen scaffold
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Leilei ZhuUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 19 Oct 2015 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HUCMSC injection | Experimental | Biological: HUCMSC injectiononce intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells |
| collagen scaffolds/HUCMSC injection | Experimental | Biological: collagen scaffolds/HUCMSC injectiononce intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells |
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): PSV <25 cm/sec, or PSV >25 cm/sec, EDV>5cm/sec, 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 |
|---|---|---|
| HUCMSC injectionThe subjects will receive intracavernous injection of HUCMSC.' | Biological | HUCMSC injection |
| collagen scaffolds/HUCMSC injectionThe subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.' | Biological | collagen scaffolds/HUCMSC injection |
Primary outcome
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.
2 secondary outcomes
Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection
Time frame: 1,3,6,9 and 12 months
Safety and Tolerability assessed by Adverse Events
Time frame: 1 month after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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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 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 HUCMSC injection and collagen scaffolds/HUCMSC injection in people with Erectile Dysfunction and Type 1 Diabetes Mellitus, run by Leilei Zhu 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: withdrawn, as of the sponsor's last update on 8 Apr 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvements in IIEF scores (time frame: 1,3,6,9 and 12 months). 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 8 Apr 2016.