Clinical trial NCT02648386: Stem Cell Therapy Combined With NeuroRegen Scaffold™ in Patients With Erectile Dysfunction After Rectal Cancer Surgery
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Rectal Cancer
Erectile Dysfunction
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2016-01-07
Enrollment: 34
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Tolerability assessed by Adverse Events
timeFrame: Up to 6 months
Secondary outcomes:
measure: IIEF-5 (International Index of Erectile Function)
timeFrame: 1, 3, 6, 12 months
measure: Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3
timeFrame: 1, 3, 6, 12 months
measure: Penile cavernosal artery peak systolic velocity (PSV)
timeFrame: 1, 3, 6, 12 months
measure: Nocturnal penile tumescence (NPT)
timeFrame: 1, 3, 6, 12 months
measure: The change of results of Nerve electrophysiological examination
timeFrame: 1, 3, 6, 12 months
measure: Maximum Flow Rate (Qmax)
timeFrame: 1, 3, 6, 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: