Erectile Dysfunction Clinical Trial
Official title:
Effectiveness and Safety of Intracavernosal Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years to 75 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | 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 | |
Russian Federation | I.M. Sechenov First Moscow State Medical University | Moscow |
Lead Sponsor | Collaborator |
---|---|
Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati | I.M. Sechenov First Moscow State Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SAEs monitoring | Types, probability and severity of treatment emergent serious adverse events (SAEs) | 2 weeks after treatment | Yes |
Primary | SARs monitoring | Types, probability and severity of treatment emergent serious adverse reactions (SARs) | 2 weeks after treatment | Yes |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | Endothelial function assessment | Endothelial function assessed by EndoPAT or similar device measurements. | Follow up to completion (up to 24 weeks after treatment) | No |
Secondary | Arterial stiffness assessment | Arterial stiffness assessed by EndoPAT or similar device measurements. | Follow up to completion (up to 24 weeks after treatment) | No |
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