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| Name | Class |
|---|---|
| I.M. Sechenov First Moscow State Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADRC injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracavernosal administration of autologous ADRC | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SAEs monitoring | Types, probability and severity of treatment emergent serious adverse events (SAEs) | 2 weeks after treatment |
| SARs monitoring | Types, probability and severity of treatment emergent serious adverse reactions (SARs) | 2 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Follow up to completion (up to 24 weeks after treatment) |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
Dropout Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University | Moscow | 119991 | Russia | |||
| 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 |
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|
| Liposuction | Procedure |
|
| ADRC isolation | Device | ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol |
|
| 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. |
| Follow up to completion (up to 24 weeks after treatment) |
| Endothelial function assessment | Endothelial function assessed by EndoPAT or similar device measurements. | Follow up to completion (up to 24 weeks after treatment) |
| Arterial stiffness assessment | Arterial stiffness assessed by EndoPAT or similar device measurements. | Follow up to completion (up to 24 weeks after treatment) |
| Moscow |
| 121359 |
| Russia |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D018783 | Impotence, Vasculogenic |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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