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

NCT02472431 | Completed Phase 1

• 1 other identifier: RU-CCH-01-01-15
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Quality of life monitoring

  Follow up to completion (up to 24 weeks after treatment)

• Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection

  Follow up to completion (up to 24 weeks after treatment)

• Endothelial function assessment

  Follow up to completion (up to 24 weeks after treatment)

• Arterial stiffness assessment

  Follow up to completion (up to 24 weeks after treatment)

Study Arms (1)

ADRC injection

EXPERIMENTAL

Other: Intracavernosal administration of autologous ADRC; Procedure: Liposuction; Device: ADRC isolation

Interventions

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.

ADRC injection

Liposuction PROCEDURE

ADRC injection

ADRC isolation DEVICE

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

ADRC injection

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation: lead
• I.M. Sechenov First Moscow State Medical University: collaborator

Study Sites (2)

I.M. Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

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, 121359, Russia

Location

MeSH Terms

Conditions

Erectile Dysfunction; Impotence, Vasculogenic

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 15, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-11

Locations

RU (2)