Stem Cell Therapy Combined With NeuroRegen Scaffold™ in Patients With Erectile Dysfunction After Rectal Cancer Surgery

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02648386
• Other study ID #: CAS-XDA-ED-IGDB
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: December 2015
• Source: Chinese Academy of Sciences
• Contact: Yutian Dai, M.D.
• Phone: 86-25-83106666
• Email: 13913957628[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 scaffold transplantation in men with erectile dysfunction after rectal cancer treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with local rectal cancer, which is within 12cm from anus.

2. Male, 20-65 years old.

3. IIEF-5 score> 21.

4. No obvious abnormal in external genitalia, testis, epididymis and spermatic cord.

5. Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.

6. Signed informed consent.

7. Recently take no drugs affecting sexual function (such as androgen replacement drugs, PDE5i and Chinese patent medicine, etc.).

Exclusion Criteria:

1. Suffering hypertension or diabetes.

2. In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery.

3. Patient's partner is trying to conceive during the trial period.

4. 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.

5. Geographically inaccessible for follow-up visits required by protocol or want to other treatment.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Laparoscopic surgery
Completely resected rectal tumor.

Device:
• NeuroRegen scaffold transplantation
After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.

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.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability assessed by Adverse Events		Up to 6 months
Secondary	IIEF-5 (International Index of Erectile Function)	Improvements in sexual function based on the (IIEF)-5 questionnaire	1, 3, 6, 12 months
Secondary	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.	1, 3, 6, 12 months
Secondary	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.	1, 3, 6, 12 months
Secondary	Nocturnal penile tumescence (NPT)	Monitor penis erection during sleep to assess erection function of the patients.	1, 3, 6, 12 months
Secondary	The change of results of Nerve electrophysiological examination	To assess the penile sensory pathway abnormalities of the patients with or without premature ejaculation.	1, 3, 6, 12 months
Secondary	Maximum Flow Rate (Qmax)	Change of the maximum flow rate (Qmax) to assess the bladder function.	1, 3, 6, 12 months