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

NCT ID: NCT02472431

Last Updated: 2016-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-11-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADRC injection

Group Type: EXPERIMENTAL

Intracavernosal administration of autologous ADRC

Intervention Type: 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.

Liposuction

Intervention Type: PROCEDURE

ADRC isolation

Intervention Type: DEVICE

ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol

Interventions

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.

Intervention Type: OTHER

Liposuction

Intervention Type: PROCEDURE

ADRC isolation

ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey A Pulin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

Mikhail E Chalyy, MD, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

I.M. Sechenov First Moscow State Medical University

Locations

I.M. Sechenov First Moscow State Medical University

Moscow, , 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

Moscow, , Russia

Countries

Russia

Other Identifiers

RU-CCH-01-01-15

Identifier Type: -

Identifier Source: org_study_id