Clinical trial NCT02472431: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Sponsor class: OTHER_GOV
Collaborators: name: I.M. Sechenov First Moscow State Medical University
First posted: 2015-06-15
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: SAEs monitoring
timeFrame: 2 weeks after treatment
measure: SARs monitoring
timeFrame: 2 weeks after treatment
Secondary outcomes:
measure: Quality of life monitoring
timeFrame: Follow up to completion (up to 24 weeks after treatment)
measure: Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection
timeFrame: Follow up to completion (up to 24 weeks after treatment)
measure: Endothelial function assessment
timeFrame: Follow up to completion (up to 24 weeks after treatment)
measure: Arterial stiffness assessment
timeFrame: Follow up to completion (up to 24 weeks after treatment)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: 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
Study officials:
affiliation: Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
name: Andrey A Pulin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: I.M. Sechenov First Moscow State Medical University
name: Mikhail E Chalyy, MD, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References: