Stem Cell Therapy Combined With NeuroRegen Scaffold™ in Patients With Erectile Dysfunction After Rectal Cancer Surgery
NCT ID: NCT02648386
Last Updated: 2019-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2016-01-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Laparoscopic surgery
Patients receive no interventions after rectal cancer treatment.
Laparoscopic surgery
Completely resected rectal tumor.
NeuroRegen scaffold transplantation
Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.
NeuroRegen scaffold transplantation
After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.
NeuroRegen scaffold/BMMCs transplantation
Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
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
Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
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.
Interventions
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Laparoscopic surgery
Completely resected rectal tumor.
NeuroRegen scaffold transplantation
After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
65 Years
MALE
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Principal Investigators
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Jianwu Dai, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Sciences
Locations
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAS-XDA-ED-IGDB
Identifier Type: -
Identifier Source: org_study_id
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