Recombinant Human Plasma Gelsolin for Decompression Sickness

Overseen By Howard Levy, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioAegis Therapeutics Inc.

Must not be taking: Chemotherapy, Immunomodulatory biologics

Disqualifiers: Cardiac shunt, Cancer, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for decompression sickness, a condition affecting SCUBA divers who ascend too quickly. Researchers are testing a protein called recombinant human plasma gelsolin to determine if it can reduce symptoms by managing inflammation. Participants will be divided into three groups to receive different treatments before and after a simulated dive in a hyperbaric chamber. The trial seeks healthy, trained SCUBA divers without other health conditions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are being treated with systemic chemotherapy, immunomodulatory biologics, or radiation therapy, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that recombinant human plasma gelsolin (rhu-pGSN) has been tested in people and is generally well-tolerated. Previous studies found that this treatment can reduce inflammation without causing major side effects. In other trials, rhu-pGSN effectively managed conditions related to inflammation, with no significant safety concerns reported. This trial, being a Phase 2 study, indicates that earlier tests deemed rhu-pGSN safe enough to continue studying its effects on decompression sickness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Recombinant human plasma gelsolin (rhu-pGSN) is unique because it offers a new approach to treating decompression sickness by potentially stabilizing cell membranes and reducing inflammation. Unlike traditional treatments like hyperbaric oxygen therapy, which focuses on pressure changes to alleviate symptoms, rhu-pGSN works at the molecular level to directly address the underlying cellular damage. Researchers are excited about rhu-pGSN because it may provide faster relief and prevent long-term complications, offering a promising alternative or complement to existing therapies.

What evidence suggests that recombinant human plasma gelsolin might be an effective treatment for decompression sickness?

Research shows that recombinant human plasma gelsolin (rhu-pGSN) might help with decompression sickness (DCS). Studies have found that people with DCS often have lower levels of plasma gelsolin and higher levels of inflammatory substances. The treatment, rhu-pGSN, aims to reduce inflammation by restoring gelsolin levels. In animal studies, rhu-pGSN decreased inflammation in the brain and aided recovery in areas affected by DCS. This trial will evaluate rhu-pGSN administered either before or after hyperbaric chamber exposure. These findings suggest that rhu-pGSN could effectively lessen the harmful effects of DCS in people. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for healthy, trained SCUBA divers aged 18 or older without underlying health issues. Participants must consent and agree not to donate sperm or eggs. Women who can have children must use two approved birth control methods; men with partners at risk of pregnancy must also use reliable contraception.

Inclusion Criteria

You have given permission to take part in the study.

You agree not to donate sperm or eggs during the study.

I am a healthy, trained SCUBA diver with no known health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Exposure Assessment

Participants undergo medical history recording, physical examination, EKG, lab tests, and pre-exposure blood sampling

1 day

1 visit (in-person)

High-Pressure Exposure and Treatment

Participants are exposed to high pressure in a hyperbaric chamber and receive either rhu-pGSN or saline treatment

1 day

1 visit (in-person)

Immediate Post-Exposure Monitoring

Blood samples collected at multiple time points post-exposure to assess inflammatory markers and gas bubbles

24 hours

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including blood sample collection and well-being questionnaire

14 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Recombinant human plasma gelsolin

Trial Overview The study tests if recombinant human plasma gelsolin (rhu-pGSN) can reduce inflammation from decompression in divers. Divers are put into three groups: one gets saline before and after a simulated dive, another gets rhu-pGSN before the dive, and the last group gets it afterward.

How Is the Trial Designed?

Group I: rhu-pGSN pre-exposure Active Control 3 Interventions

rhu-pGSN 24 mg/kg IV immediately prior to hyperbaric chamber exposure, and sterile normal saline 0.9% IV immediately after exposure

Group II: rhu-pGSN post-exposure Active Control 3 Interventions

Sterile normal saline 0.9% IV immediately prior to hyperbaric chamber exposure, and rhu-pGSN 24 mg/kg IV immediately after exposure

Group III: Control Placebo Group 3 Interventions

Sterile normal saline 0.9% IV immediately prior to hyperbaric chamber exposure, and immediately after exposure

Who Is Running the Clinical Trial?

BioAegis Therapeutics Inc.

Lead Sponsor

Trials

5

Recruited

770+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06216366?term=NCT06216366&limit=10&sort=@relevance&rank=1

Study Details | NCT06216366 | Rhu-pGSN to Mitigate ... Healthy trained divers will be exposed to a high-pressure profile known to cause decreased plasma gelsolin (pGSN), increased microparticles (MPs), and cytokine ...

2. bioaegistherapeutics.com bioaegistherapeutics.com/pipeline-validating-efficacy/

Pipeline Validating Efficacy | Lead Ind: ARDS Treating patients with recombinant human plasma gelsolin (rhu-pGSN) holds much promise for addressing the over exuberant inflammatory response that can lead to ...

3. bioaegistherapeutics.com bioaegistherapeutics.com/news/august-20-2025-bioaegis-therapeutics-awarded-second-fda-fast-track-designation-for-recombinant-human-gelsolin-to-treat-inflammasome-driven-decompression-sickness-dcs/

August 20, 2025: BioAegis Therapeutics Awarded Second ... Previous research has shown that individuals with DCS exhibit depleted plasma gelsolin levels and elevated inflammatory microparticles, features ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39475490

Recombinant human plasma gelsolin suppresses persistent ... Recombinant human plasma gelsolin suppresses persistent neuroinflammation and restores hippocampal neurogenesis in murine model of decompression ...

5. withpower.com withpower.com/trial/phase-2-decompression-sickness-5-2024-8fa28

Recombinant Human Plasma Gelsolin for Decompression ... This Phase 2 medical study run by BioAegis Therapeutics Inc. needs participants to evaluate whether Recombinant human plasma gelsolin will have tolerable ...

6. globenewswire.com globenewswire.com/news-release/2025/08/20/3136592/0/en/BioAegis-Therapeutics-Awarded-Second-FDA-Fast-Track-Designation-for-Recombinant-Human-Gelsolin-to-Treat-Inflammasome-Driven-Decompression-Sickness-DCS.html

BioAegis Therapeutics Awarded Second FDA Fast Track BioAegis Therapeutics Awarded Second FDA Fast Track Designation for Recombinant Human Gelsolin to Treat Inflammasome-Driven Decompression ...