← Back to Search

Cell Therapy

Injection of adipose derived cells into penis for Erectile Dysfunction

N/A

Waitlist Available

Research Sponsored by Tissue Genesis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic, organic ED, duration at least 0.5 years, with baseline IIEF-EF score of 11-22

Willing to limit alcohol intake and eliminate use of recreational drugs for sexual encounters

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will investigate whether fat cells from a person's own body can be used to restore erectile function in men with ED.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have had trouble with getting or maintaining erections for at least 6 months, and your score on a specific questionnaire is between 11 and 22.

Select...

You agree to drink less alcohol and avoid using drugs when engaging in sexual activities.

Select...

You have enough fat in your abdomen for two liposuction procedures, each removing about 60-120 cc of fat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Efficacy Objective: ability of adipose derived cells to restore erectile function using the 6-Item IIEF-EF score

Secondary outcome measures

Safety Objective: assessment of any adverse events

Trial Design

2Treatment groups

Experimental Treatment

Group I: ARM 2Experimental Treatment1 Intervention

Sham control saline injection procedure followed six months later by injection of adipose derived cells into penis

Group II: ARM 1Experimental Treatment1 Intervention

Injection of adipose derived cells into penis followed six months later with sham control saline injection procedure

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tissue GenesisLead Sponsor

3 Previous Clinical Trials

110 Total Patients Enrolled

1 Trials studying Erectile Dysfunction

30 Patients Enrolled for Erectile Dysfunction

Paul Kosnik, PhDStudy ChairSponsor GmbH

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare centers are conducting this research endeavor?

"This medical study is enrolling participants from San Diego Sexual Medicine in California, Johns Hopkins Kimmel Cancer Center in Maryland and James A. Simon in the District of Columbia as well as 5 other facilities."

Answered by AI

Is there still capacity for new participants in this clinical investigation?

"The information hosted on clinicaltrials.gov states that this medical trial is no longer recruiting patients; the initial posting was April 1st 2022 and it has been modified as recently as June 23rd 2021. At present, 62 alternative medical studies are actively searching for participants."

Answered by AI

Who else is applying?

What state do they live in?

Florida

Other

Texas

California

How old are they?

65+

18 - 65

What site did they apply to?

James A. Simon

Other

Scott Department of Urology, Baylor College of Medicine

San Diego Sexual Medicine

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

What questions have other patients asked about this trial?

Do I need to be insured? What evidence leads you to believe this may be an effective approach; and what are the risks of the procedure? How are results measured ( objectively, subjectively)?

PatientReceived 1 prior treatment

Why did patients apply to this trial?

I’m insecure of my ed. Hoping to help myself and others. Looking for help in the erection department.

PatientReceived no prior treatments

i need treatment for erectile disfunction other than what im taking. I would like to start a trail on this . Have not taken prior medication or injections for ED.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction

2022. "Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03518333.

All > Erectile Dysfunction