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

Chinese Academy of Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Erectile Dysfunction; Rectal Cancer

Treatments: Procedure: Laparoscopic surgery; Biological: NeuroRegen scaffold/HUC-MSCs transplantation; Device: NeuroRegen scaffold transplantation; Biological: NeuroRegen scaffold/BMMCs transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02648386

CAS-XDA-ED-IGDB

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 4 patient groups

Laparoscopic surgery

Sham Comparator group

Description:

Patients receive no interventions after rectal cancer treatment.

Treatment:

Procedure: Laparoscopic surgery

NeuroRegen scaffold transplantation

Experimental group

Description:

Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.

Treatment:

Device: NeuroRegen scaffold transplantation

NeuroRegen scaffold/BMMCs transplantation

Experimental group

Description:

Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment.

Treatment:

Biological: NeuroRegen scaffold/BMMCs transplantation

NeuroRegen scaffold/HUC-MSCs transplantation

Experimental group

Description:

Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment.

Treatment:

Biological: NeuroRegen scaffold/HUC-MSCs transplantation