Rectal CancerPhase 1/2NCT02648386
Stem Cell Therapy Combined With NeuroRegen Scaffold™ in Patients With Erectile Dysfunction After Rectal Cancer Surgery
A Phase 1/2 study testing Laparoscopic surgery, NeuroRegen scaffold transplantation and NeuroRegen scaffold/BMMCs transplantation in people with Rectal Cancer and Erectile Dysfunction, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer treatment. The purpose of this study is to assess the safety and efficacy of autologous bone marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) combined with NeuroRegen… Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Rectal Cancer, Erectile Dysfunction
- What is being tested?
- Laparoscopic surgery, NeuroRegen scaffold transplantation and NeuroRegen scaffold/BMMCs transplantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2020
- Phase
- Phase 1/2
- 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
- Diagnosed with local rectal cancer, which is within 12cm from anus.
- Male, 20-65 years old.
- IIEF-5 score> 21.
- No obvious abnormal in external genitalia, testis, epididymis and spermatic cord.
- Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.
- Signed informed consent.
- Recently take no drugs affecting sexual function (such as androgen replacement drugs, PDE5i and Chinese patent medicine, etc.).
Who cannot join
- Suffering hypertension or diabetes.
- In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery.
- Patient's 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.
- Geographically inaccessible for follow-up visits required by protocol or want to other treatment.
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: Bone Marrow Mononuclear Cells or Human Umbilical Cord-derived Mesenchymal Stem Cells Combined With NeuroRegen Scaffold™ Transplantation for the Improvement of Erectile Function in Men After Rectal Cancer Surgery
Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer treatment. The purpose of this study is to assess the safety and efficacy of autologous bone marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) combined with NeuroRegen scaffold transplantation in men with erectile dysfunction after rectal cancer treatment.
- Conditions
- Rectal Cancer, Erectile Dysfunction
- Being tested
- Laparoscopic surgery, NeuroRegen scaffold transplantation, NeuroRegen scaffold/BMMCs transplantation, NeuroRegen scaffold/HUC-MSCs transplantation
- Medical subject headings
- Rectal Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
Completely resected rectal tumor.
NeuroRegen scaffold transplantationDevice
After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.
NeuroRegen scaffold/BMMCs transplantationBiological
Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million bone marrow mononuclear cells to the nerve.
NeuroRegen scaffold/HUC-MSCs transplantationBiological
Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million human umbilical cord mesenchymal cells to the nerve.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | Sham comparator | Patients receive no interventions after rectal cancer treatment. Receives: Procedure: Laparoscopic surgery |
| NeuroRegen scaffold transplantation | Experimental | Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment. Receives: Device: NeuroRegen scaffold transplantation |
| NeuroRegen scaffold/BMMCs transplantation | Experimental | Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment. Receives: Biological: NeuroRegen scaffold/BMMCs transplantation |
| NeuroRegen scaffold/HUC-MSCs transplantation | Experimental | Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment. Receives: Biological: NeuroRegen scaffold/HUC-MSCs transplantation |
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: Up to 6 months
Secondary outcomes (6)
IIEF-5 (International Index of Erectile Function)
Improvements in sexual function based on the (IIEF)-5 questionnaire
Measured: 1, 3, 6, 12 months
Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3
Changes in mean scores of Sexual Encounter Profile (SEP) Question 2 and 3 will be evaluated and reported.
Measured: 1, 3, 6, 12 months
Penile cavernosal artery peak systolic velocity (PSV)
Changes in penile cavernosal artery peak systolic velocity in [cm/s] as determined by Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection.
Measured: 1, 3, 6, 12 months
Nocturnal penile tumescence (NPT)
Monitor penis erection during sleep to assess erection function of the patients.
Measured: 1, 3, 6, 12 months
The change of results of Nerve electrophysiological examination
To assess the penile sensory pathway abnormalities of the patients with or without premature ejaculation.
Measured: 1, 3, 6, 12 months
Maximum Flow Rate (Qmax)
Change of the maximum flow rate (Qmax) to assess the bladder function.
Measured: 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- 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 Rectal CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 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
- NCT02648386
- Sponsor's protocol ID
- CAS-XDA-ED-IGDB
- Status last verified
- Dec 2015
- First submitted
- 5 Jan 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
- Bone Marrow Mononuclear Cells or Human Umbilical Cord-derived Mesenchymal Stem Cells Combined With NeuroRegen Scaffold™ Transplantation for the Improvement of Erectile Function in Men After Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT02648386
- Acronym / sponsor ID
- CAS-XDA-ED-IGDB
- Conditions
- Rectal Cancer, Erectile Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- Jan 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Jan 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.
Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer treatment. The purpose of this study is to assess the safety and efficacy of autologous bone marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) combined with NeuroRegen scaffold transplantation in men with erectile dysfunction after rectal cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | Sham comparator | Procedure: Laparoscopic surgeryPatients receive no interventions after rectal cancer treatment. |
| NeuroRegen scaffold transplantation | Experimental | Device: NeuroRegen scaffold transplantationPatients receive NeuroRegen scaffold transplantation after rectal cancer treatment. |
| NeuroRegen scaffold/BMMCs transplantation | Experimental | Biological: NeuroRegen scaffold/BMMCs transplantationPatients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment. |
| NeuroRegen scaffold/HUC-MSCs transplantation | Experimental | Biological: NeuroRegen scaffold/HUC-MSCs transplantationPatients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with local rectal cancer, which is within 12cm from anus.
- Male, 20-65 years old.
- IIEF-5 score> 21.
- No obvious abnormal in external genitalia, testis, epididymis and spermatic cord.
- Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.
Key exclusion criteria (5 listed)
- Suffering hypertension or diabetes.
- In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery.
- Patient's 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.
- Geographically inaccessible for follow-up visits required by protocol or want to other treatment.
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 |
|---|---|---|
| Laparoscopic surgeryCompletely resected rectal tumor. | Procedure or surgery | Laparoscopic surgery |
| NeuroRegen scaffold transplantationAfter completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve. | Device | NeuroRegen scaffold transplantation |
| NeuroRegen scaffold/BMMCs transplantationCompletely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million bone marrow mononuclear cells to the nerve. | Biological | NeuroRegen scaffold/BMMCs transplantation |
| NeuroRegen scaffold/HUC-MSCs transplantationCompletely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million human umbilical cord mesenchymal cells to the nerve. | Biological | NeuroRegen scaffold/HUC-MSCs transplantation |
Primary outcome
Safety and Tolerability assessed by Adverse Events
Time frame: Up to 6 months
6 secondary outcomes
IIEF-5 (International Index of Erectile Function)
Time frame: 1, 3, 6, 12 months
Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3
Time frame: 1, 3, 6, 12 months
Penile cavernosal artery peak systolic velocity (PSV)
Time frame: 1, 3, 6, 12 months
Nocturnal penile tumescence (NPT)
Time frame: 1, 3, 6, 12 months
The change of results of Nerve electrophysiological examination
Time frame: 1, 3, 6, 12 months
Maximum Flow Rate (Qmax)
Time frame: 1, 3, 6, 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.
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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, 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 1/2 study testing Laparoscopic surgery, NeuroRegen scaffold transplantation and NeuroRegen scaffold/BMMCs transplantation in people with Rectal Cancer and Erectile Dysfunction, 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 7 inclusion and 5 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yutian Dai, M.D. (86-25-83106666 ext. 70502, 13913957628@163.com), 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: Up to 6 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 25 Jan 2019.