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AzTrials

Erectile DysfunctionPhase 1/2NCT02472431

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

A Phase 1/2 study testing Intracavernosal administration of autologous ADRC, Liposuction and ADRC isolation in people with Erectile Dysfunction and Impotence, Vasculogenic, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 2 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years, men only
Conditions the study is for
Erectile Dysfunction, Impotence, Vasculogenic
What is being tested?
Intracavernosal administration of autologous ADRC, Liposuction and ADRC isolation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesRussia
Study dates
Apr 2015to Nov 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 20Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

  • I.M. Sechenov First Moscow State Medical University

    Moscow, 119991

  • 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

Other trials in Russia

About this study

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.

Read the 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.

Being tested
Intracavernosal administration of autologous ADRC, Liposuction, ADRC isolation
Keywords
ADRC, Adipose-Derived Regenerative Cells, Fat Tissue, Stem Cells, Erectile Dysfunction, Arteriogenic Impotence, Venogenic Impotence, Vasculogenic Impotence, Male Impotence, Male Sexual Impotence
Medical subject headings
Erectile Dysfunction, Impotence, Vasculogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracavernosal administration of autologous ADRCOther

    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.

  • LiposuctionProcedure or surgery

  • ADRC isolationDevice

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

Study groups in NCT02472431
Study groupRoleWhat they receive
ADRC injectionExperimentalNot described
Receives: Other: Intracavernosal administration of autologous ADRC; Procedure: Liposuction; Device: ADRC isolation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SAEs monitoring

    Types, probability and severity of treatment emergent serious adverse events (SAEs)

    Measured: 2 weeks after treatment

  2. SARs monitoring

    Types, probability and severity of treatment emergent serious adverse reactions (SARs)

    Measured: 2 weeks after treatment

Secondary outcomes (4)

  1. 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)

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

  2. 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.

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

  3. Endothelial function assessment

    Endothelial function assessed by EndoPAT or similar device measurements.

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

  4. Arterial stiffness assessment

    Arterial stiffness assessed by EndoPAT or similar device measurements.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02472431
Sponsor's protocol ID
RU-CCH-01-01-15
Status last verified
Nov 2016
First submitted
9 Jun 2015
Last updated
30 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Intracavernosal administration of autologous ADRC, Liposuction and ADRC isolation in people with Erectile Dysfunction and Impotence, Vasculogenic, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAEs monitoring (time frame: 2 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02472431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.

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