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
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Chinese Academy of Sciences
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability assessed by Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- 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>
- •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.
Arms & Interventions
Laparoscopic surgery
Patients receive no interventions after rectal cancer treatment.
Intervention: Laparoscopic surgery (Procedure)
NeuroRegen scaffold transplantation
Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.
Intervention: NeuroRegen scaffold transplantation (Device)
NeuroRegen scaffold/BMMCs transplantation
Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
Intervention: NeuroRegen scaffold/BMMCs transplantation (Biological)
NeuroRegen scaffold/HUC-MSCs transplantation
Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
Intervention: NeuroRegen scaffold/HUC-MSCs transplantation (Biological)
Outcomes
Primary Outcomes
Safety and Tolerability assessed by Adverse Events
Time Frame: Up to 6 months
Secondary Outcomes
- Nocturnal penile tumescence (NPT)(1, 3, 6, 12 months)
- Maximum Flow Rate (Qmax)(1, 3, 6, 12 months)
- IIEF-5 (International Index of Erectile Function)(1, 3, 6, 12 months)
- Penile cavernosal artery peak systolic velocity (PSV)(1, 3, 6, 12 months)
- Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3(1, 3, 6, 12 months)
- The change of results of Nerve electrophysiological examination(1, 3, 6, 12 months)
Investigators
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences