Stem Cell Therapy Combined With NeuroRegen Scaffold™ in Patients With Erectile Dysfunction After Rectal Cancer Surgery
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ClinicalTrials.gov Identifier: NCT02648386 |
Recruitment Status : Unknown
Verified December 2015 by Jianwu Dai, Chinese Academy of Sciences.
Recruitment status was: Recruiting
First Posted : January 7, 2016
Last Update Posted : January 25, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rectal Cancer Erectile Dysfunction | Procedure: Laparoscopic surgery Device: NeuroRegen scaffold transplantation Biological: NeuroRegen scaffold/BMMCs transplantation Biological: NeuroRegen scaffold/HUC-MSCs transplantation | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Sham Comparator: Laparoscopic surgery
Patients receive no interventions after rectal cancer treatment.
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Procedure: Laparoscopic surgery
Completely resected rectal tumor. |
Experimental: NeuroRegen scaffold transplantation
Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.
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Device: NeuroRegen scaffold transplantation
After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve. |
Experimental: NeuroRegen scaffold/BMMCs transplantation
Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
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Biological: NeuroRegen scaffold/BMMCs transplantation
Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million bone marrow mononuclear cells to the nerve. |
Experimental: NeuroRegen scaffold/HUC-MSCs transplantation
Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
|
Biological: NeuroRegen scaffold/HUC-MSCs transplantation
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. |
- Safety and Tolerability assessed by Adverse Events [ Time Frame: Up to 6 months ]
- IIEF-5 (International Index of Erectile Function) [ Time Frame: 1, 3, 6, 12 months ]Improvements in sexual function based on the (IIEF)-5 questionnaire
- Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3 [ Time Frame: 1, 3, 6, 12 months ]Changes in mean scores of Sexual Encounter Profile (SEP) Question 2 and 3 will be evaluated and reported.
- Penile cavernosal artery peak systolic velocity (PSV) [ Time Frame: 1, 3, 6, 12 months ]Changes in penile cavernosal artery peak systolic velocity in [cm/s] as determined by Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection.
- Nocturnal penile tumescence (NPT) [ Time Frame: 1, 3, 6, 12 months ]Monitor penis erection during sleep to assess erection function of the patients.
- The change of results of Nerve electrophysiological examination [ Time Frame: 1, 3, 6, 12 months ]To assess the penile sensory pathway abnormalities of the patients with or without premature ejaculation.
- Maximum Flow Rate (Qmax) [ Time Frame: 1, 3, 6, 12 months ]Change of the maximum flow rate (Qmax) to assess the bladder function.

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Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.).
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648386
Contact: Yutian Dai, M.D. | 86-25-83106666 ext 70502 | 13913957628@163.com | |
Contact: Sufang Han, Ph.D. | 86-10-82614420 | sufanghan22@genetics.ac.cn |
China, Jiangsu | |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting |
Nanjing, Jiangsu, China, 210008 | |
Contact: Yutian Dai, M.D. 86-25-83106666 ext 70502 13913957628@163.com | |
Contact: LeiLei Zhu, M.D. 86-25-83106666 ext 70502 zhuleilei68n@163.com |
Principal Investigator: | Jianwu Dai, Ph.D. | Chinese Academy of Sciences |
Responsible Party: | Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences |
ClinicalTrials.gov Identifier: | NCT02648386 |
Other Study ID Numbers: |
CAS-XDA-ED-IGDB |
First Posted: | January 7, 2016 Key Record Dates |
Last Update Posted: | January 25, 2019 |
Last Verified: | December 2015 |
Rectal Neoplasms Erectile Dysfunction Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |