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Adipose-derived SVF for Erectile Dysfunction

Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: GID BIO, Inc.
Must be taking: PDE5 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for erectile dysfunction (ED) using a single injection of a patient's own fat-derived cells (GID SVF-2). The goal is to determine if this approach is safe and can improve ED symptoms. It suits individuals who have experienced ED for at least three months and have been using ED medication (such as Viagra) but are willing to stop during the study. Participants must have the same sexual partner throughout the trial and speak English. Those who haven't responded to ED medications or have certain medical conditions are not eligible. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for ED.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any PDE5 inhibitors (medications for erectile dysfunction) for the duration of the study. If you are currently taking blood thinners, cancer drugs, or HIV drugs, you cannot participate in the trial.

What prior data suggests that this treatment is safe for erectile dysfunction?

A previous study demonstrated that using a person's own fat cells, known as stromal vascular fraction (SVF), was safe when injected into the face for certain treatments. No serious side effects occurred, and some individuals even experienced improvements over time. Another study examined SVF for knee pain and found it was well-tolerated, with no significant negative reactions.

Research has also shown that injecting SVF into the hands of patients with systemic sclerosis was safe, as participants did not report serious issues during the study. These findings support the general safety of SVF injections for various conditions.

While the current study focuses on the safety of SVF for erectile dysfunction, past research suggests that the treatment should be well-tolerated.12345

Why are researchers excited about this trial?

Unlike the standard treatments for erectile dysfunction, such as pills, injections, or devices, GID SVF-2 is unique because it uses your body's own cells to help address the issue. Researchers are excited about this treatment because it involves a single injection of autologous adipose-derived stromal vascular fraction (SVF), which is a fancy way of saying it uses cells harvested from your own fat tissue. This approach could potentially repair and regenerate the affected tissues, offering a more natural and potentially longer-lasting solution. While most current treatments focus on symptom management, this innovative method targets the underlying issues, which could mean fewer side effects and a more sustainable improvement in erectile function.

What evidence suggests that this treatment might be an effective treatment for erectile dysfunction?

Research has shown that a treatment called adipose-derived stromal vascular fraction (SVF) therapy, such as GID SVF-2, can reduce pain and improve movement. Studies focused on knee osteoarthritis have demonstrated that SVF treatment significantly decreases pain over time. This trial involves participants receiving a single injection of GID SVF-2, which uses cells from their own fat tissue to reduce inflammation and aid healing. Early results suggest it might also help with other conditions by lowering inflammation. Although limited data exists on its use for erectile dysfunction, its mechanism shows promise for treating various conditions.16789

Are You a Good Fit for This Trial?

Inclusion Criteria

Both the subject and the partner are willing to give consent freely and voluntarily.
I can speak, read, and understand English.
I have been taking a phosphodiesterase type 5 inhibitor for at least 1 month prior, and I am willing to stop taking any phosphodiesterase type 5 inhibitor for the duration of the study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of autologous adipose-derived stromal vascular fraction (SVF)

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Visits at 30 days, 3 months, and 6 months

Long-term follow-up

Monitoring of adverse events

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • GID SVF-2
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GID BIO, Inc.

Lead Sponsor

Trials
5
Recruited
190+

Citations

Stromal vascular fraction therapy for knee osteoarthritisfound that SVF treatment improved pain and functionality since a reduction in the mean VAS (from 5.1; SD: 1.2 at 12 months to 3.4; SD: 1.8 at 24 months) and ...
Autologous Adipose-derived Stromal Vascular Fraction for ...This is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device ...
Adipose-derived SVF for the Treatment of Knee OAThe study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for ...
Efficacy of adipose-derived stem cells and stromal vascular ...At 12 months, SVF therapy achieved significant short-term pain reduction, with a mean VAS improvement of 18.10 points, compared to 16.92 points for ADMSC- ...
Use of Autologous Adipose-Derived Stromal Vascular Fraction ...Recent studies on animal and human subjects have shown the efficacy of adipose- derived stem/stromal vascular fraction cells to decrease inflammation and pain ...
Safety of adipose-derived stromal vascular fraction cells to ...Autologous ADSVF via facial injections to treat PD was safe, showed evidence of clinical improvement at 12 and 24 months and should be further evaluated.
SVF-2 TechnologyA study evaluating the safety of adipose-derived SVF for intra-articular injection of the knee and the feasibility of an intra-articular injection for pain ...
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/25114060/
Safety, tolerability and potential efficacy of injection ...This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months suggest potential ...
Autologous Adipose-derived Stromal Vascular Fraction for ...This study is an early feasibility study to evaluate the safety of a single intravenous injection of autologous adipose-derived SVF produced using the GID SVF-2 ...
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