Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction
Primary Purpose
Erectile Dysfunction, Impotence, Vasculogenic
Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Intracavernosal administration of autologous ADRC
Liposuction
ADRC isolation
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring ADRC, Adipose-Derived Regenerative Cells, Fat Tissue, Stem Cells, Erectile Dysfunction, Arteriogenic Impotence, Venogenic Impotence, Vasculogenic Impotence, Male Impotence, Male Sexual Impotence
Eligibility Criteria
Inclusion Criteria:
- Patient suffers from erectile dysfunction
- IIEF-5 score less than 21
- Endothelial dysfunction confirmed by EndoPAT measurements
- Patient is familiar with Participant information sheet
- Patient signed informed consent form
Non-inclusion Criteria:
- Contraindications to the local anesthesia or medical history of allergic reactions to local anesthetics
- Patient prescribed for systemic corticosteroids, immunosuppressive drugs, nonsteroidal antiinflammatory drugs, phosphodiesterase-5 inhibitors
- Medical history of penile prosthesis implantation
- Peyronie's disease
- Subcompensated or decompensated forms of chronic diseases of internal organs
- Clinically significant abnormalities in results of laboratory tests
- Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
- Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
- Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
- Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
- Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior liposuction
- Medical history of heterotopic ossifications
- Patients prescribed for glycoprotein inhibitors treatment
- Patients with infections or septic condition
Exclusion Criteria:
- Patient's refusal from the further participation in trial
- Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula)
- Confirmed syphilis, HIV, hepatitis B or C infections
- Patients with hypogonadism
Dropout Criteria:
- Direct indications on immediate initiation of treatment with drugs that have proven effect on erectile function
Sites / Locations
- I.M. Sechenov First Moscow State Medical University
- Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADRC injection
Arm Description
Outcomes
Primary Outcome Measures
SAEs monitoring
Types, probability and severity of treatment emergent serious adverse events (SAEs)
SARs monitoring
Types, probability and severity of treatment emergent serious adverse reactions (SARs)
Secondary Outcome Measures
Quality of life monitoring
Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), International Index of Erectile Function (IIEF-5), Sexual Encounter Profile (SEP), Erection Hardness Score (EHS), Global Assessment Question (GAQ)
Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection
Colour penile Doppler ultrasonography with intracavernosal injection of prostaglandin-E1 10 ug. Arterial diameter, peak systolic flow velocity, end diastolic flow velocity and resistance index measured before and 15 min after prostaglandin-E1 10ug intracavernosal injection.
Endothelial function assessment
Endothelial function assessed by EndoPAT or similar device measurements.
Arterial stiffness assessment
Arterial stiffness assessed by EndoPAT or similar device measurements.
Full Information
NCT ID
NCT02472431
First Posted
June 9, 2015
Last Updated
November 29, 2016
Sponsor
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Collaborators
I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02472431
Brief Title
Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction
Official Title
Effectiveness and Safety of Intracavernosal Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Collaborators
I.M. Sechenov First Moscow State Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time intracavernosally. This is a single arm study with no control. All patients receive cell therapy.
Detailed Description
Fat tissue obtainment:
Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.
ADRC isolation:
Aspirated fat tissue placed into sterile vessel which inserted into Celution 800/CRS System (Cytori Therapeutics Inc) - closed system for automated and standardized extraction and concentration of ADRC. Celution 800/CRS System drains excess of fluid from fat tissue and estimate it's volume After that lipoaspirate washed extensively with equal volumes of Ringer's solution to remove blood. At the end of this process System indicates required volume of enzyme reagent (Celase®) which should be added immediately by operator. After enzyme treatment Celution 800/CRS System automatically transfers isolated ADRC into washing compartment where ADRC washed and concentrated in 5 mL suspension. Tissue processing time - approximately 60 minutes. ADRC suspension match all requirements listed in technical documentation for Celution 800/CRS System. Obtained ADRC divided into 2 portions. First portion (0.2-0.5 mL) used for counting, viability and sterility assessment. Second portion placed into sterile insulin syringes with needle size 30 G for injection.
Intracavernosal injection of ADRC:
Tourniquet applied immediately prior to injection at the base of the penis. Penis and surrounding skin treated with antiseptic solution. The injection performed on lateral surface of penis bilaterally proximally into the middle and distal parts of corpus cavernosum. Needle is inserted into the corpus cavernosum at the depth of 5-7 mm. Up to 1.0 ml of ADRC suspension injected per single injection. Equal portions of ADRC suspension injected into both corpora cavernosa. Tourniquet removed 20 minutes after ADRC injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Impotence, Vasculogenic
Keywords
ADRC, Adipose-Derived Regenerative Cells, Fat Tissue, Stem Cells, Erectile Dysfunction, Arteriogenic Impotence, Venogenic Impotence, Vasculogenic Impotence, Male Impotence, Male Sexual Impotence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADRC injection
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Intracavernosal administration of autologous ADRC
Intervention Description
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After isolation autologous ADRC suspension will be injected intracavernosally.
Intervention Type
Procedure
Intervention Name(s)
Liposuction
Intervention Type
Device
Intervention Name(s)
ADRC isolation
Intervention Description
ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
Primary Outcome Measure Information:
Title
SAEs monitoring
Description
Types, probability and severity of treatment emergent serious adverse events (SAEs)
Time Frame
2 weeks after treatment
Title
SARs monitoring
Description
Types, probability and severity of treatment emergent serious adverse reactions (SARs)
Time Frame
2 weeks after treatment
Secondary Outcome Measure Information:
Title
Quality of life monitoring
Description
Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), International Index of Erectile Function (IIEF-5), Sexual Encounter Profile (SEP), Erection Hardness Score (EHS), Global Assessment Question (GAQ)
Time Frame
Follow up to completion (up to 24 weeks after treatment)
Title
Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection
Description
Colour penile Doppler ultrasonography with intracavernosal injection of prostaglandin-E1 10 ug. Arterial diameter, peak systolic flow velocity, end diastolic flow velocity and resistance index measured before and 15 min after prostaglandin-E1 10ug intracavernosal injection.
Time Frame
Follow up to completion (up to 24 weeks after treatment)
Title
Endothelial function assessment
Description
Endothelial function assessed by EndoPAT or similar device measurements.
Time Frame
Follow up to completion (up to 24 weeks after treatment)
Title
Arterial stiffness assessment
Description
Arterial stiffness assessed by EndoPAT or similar device measurements.
Time Frame
Follow up to completion (up to 24 weeks after treatment)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient suffers from erectile dysfunction
IIEF-5 score less than 21
Endothelial dysfunction confirmed by EndoPAT measurements
Patient is familiar with Participant information sheet
Patient signed informed consent form
Non-inclusion Criteria:
Contraindications to the local anesthesia or medical history of allergic reactions to local anesthetics
Patient prescribed for systemic corticosteroids, immunosuppressive drugs, nonsteroidal antiinflammatory drugs, phosphodiesterase-5 inhibitors
Medical history of penile prosthesis implantation
Peyronie's disease
Subcompensated or decompensated forms of chronic diseases of internal organs
Clinically significant abnormalities in results of laboratory tests
Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior liposuction
Medical history of heterotopic ossifications
Patients prescribed for glycoprotein inhibitors treatment
Patients with infections or septic condition
Exclusion Criteria:
Patient's refusal from the further participation in trial
Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula)
Confirmed syphilis, HIV, hepatitis B or C infections
Patients with hypogonadism
Dropout Criteria:
Direct indications on immediate initiation of treatment with drugs that have proven effect on erectile function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrey A Pulin, MD, PhD
Organizational Affiliation
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mikhail E Chalyy, MD, PhD, Prof
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
I.M. Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
12. IPD Sharing Statement
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Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction
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