Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction
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|ClinicalTrials.gov Identifier: NCT02472431|
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : November 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Impotence, Vasculogenic||Other: Intracavernosal administration of autologous ADRC Procedure: Liposuction Device: ADRC isolation||Phase 1 Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness and Safety of Intracavernosal Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
|Experimental: ADRC injection||
Other: Intracavernosal administration of autologous ADRC
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.
Device: ADRC isolation
ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
- SAEs monitoring [ Time Frame: 2 weeks after treatment ]Types, probability and severity of treatment emergent serious adverse events (SAEs)
- SARs monitoring [ Time Frame: 2 weeks after treatment ]Types, probability and severity of treatment emergent serious adverse reactions (SARs)
- Quality of life monitoring [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]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 [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]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 [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]Endothelial function assessed by EndoPAT or similar device measurements.
- Arterial stiffness assessment [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]Arterial stiffness assessed by EndoPAT or similar device measurements.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472431
|I.M. Sechenov First Moscow State Medical University|
|Moscow, Russian Federation, 119991|
|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|
|Moscow, Russian Federation, 121359|
|Principal Investigator:||Andrey A Pulin, MD, PhD||Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation|
|Principal Investigator:||Mikhail E Chalyy, MD, PhD, Prof||I.M. Sechenov First Moscow State Medical University|