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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a treatment that uses cells from a man's own body fat to help fix erectile dysfunction caused by surgery, diabetes, or blood vessel problems. The goal is to see if these cells can repair tissues and improve blood flow in the penis. Several studies have suggested the use of stem cells for the treatment of ED and showed that this type of treatment is promising in terms of damaged tissue repair.
Eligible Conditions
- Erectile Dysfunction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Efficacy Objective: ability of adipose derived cells to restore erectile function using the 6-Item IIEF-EF score
Secondary study objectives
Safety Objective: assessment of any adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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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
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