Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Status and phase

Completed

Phase 2

Phase 1

Conditions

Erectile Dysfunction

Impotence, Vasculogenic

Treatments

Other: Intracavernosal administration of autologous ADRC

Procedure: Liposuction

Device: ADRC isolation

Study type

Interventional

Funder types

Other

Identifiers

NCT02472431

RU-CCH-01-01-15

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

Male

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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: