Fractomer™ Biomatrix for Soft Tissue Injury

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: inSoma Bio, Inc.

Must not be taking: Immunosuppressants

Disqualifiers: Infections, Diabetes, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new injectable device called Fractomer™ Biomatrix in healthy volunteers. The main goal is to observe the body's reaction to this implant. Participants receive a subcutaneous injection (just under the skin) and have the implant removed after a monitoring period. Individuals who are generally healthy, have a BMI between 24 and 39.9, and can safely receive an injection might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and join the initial group exploring this innovative treatment.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants with stable anxiety or depression can join if they don't need medication. It's best to discuss your specific medications with the trial team.

What prior data suggests that this medical device is safe for implantation in healthy volunteers?

Research shows that Fractomer™ Biomatrix is being tested for safety in people, particularly healthy volunteers. This injectable material aims to support soft tissue, such as muscles or fat under the skin, after an injury.

In studies so far, Fractomer has shown promising results. Once injected, it forms a solid, sponge-like structure that remains in place and supports the surrounding tissue. This stability is crucial to prevent the material from migrating to unintended areas of the body.

Information on side effects or adverse reactions remains limited, as this is a new treatment being tested in humans for the first time. Since the study is in its early stages, it primarily focuses on understanding how the body reacts to Fractomer. Researchers are closely monitoring for any unexpected reactions or side effects.

For those considering joining this trial, it is important to know that the main goal is to ensure the treatment's safety. Participants will be closely monitored during and after the injection, allowing for quick identification and management of any issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fractomer™ Biomatrix is unique because it introduces a novel biomaterial designed to support the healing of soft tissue injuries. Unlike traditional treatments like physical therapy, anti-inflammatory medications, or surgical interventions, Fractomer A and B are implanted directly into the injury site, potentially providing a more targeted and efficient healing process. Researchers are excited about these treatments because they aim to enhance the body's natural repair mechanisms, possibly reducing recovery time and improving outcomes for patients with soft tissue injuries.

What evidence suggests that the Fractomer™ Biomatrix is effective for soft tissue injury?

This trial will compare two versions of Fractomer™ Biomatrix, Fractomer A and Fractomer B, for soft tissue injury. Studies have shown that Fractomer™ Biomatrix can aid in soft tissue repair. Research indicates that this biomatrix integrates well with body tissues and can increase fat tissue, potentially improving grafting outcomes. Early findings suggest that using Fractomer in soft tissue injuries enhances graft success by supporting the injured area. Thus, Fractomer could effectively aid the body in healing after injuries by providing a supportive structure for tissue growth. ^{1 3 4 6 7}

Who Is on the Research Team?

Trisha Shamp, PhD, PA-C

Principal Investigator

Nucleus Network

Are You a Good Fit for This Trial?

This trial is for healthy volunteers willing to test a new medical device called Fractomer™ Biomatrix. It's designed to support soft tissue after an injury. Participants will get the biomatrix injected under their skin and be monitored before it's removed.

Inclusion Criteria

BMI of 24 to 39.9, inclusive

Provision of signed and dated informed consent form

Participants must be deemed by the Investigator to be generally healthy individuals based on a medical evaluation that includes a physical examination, medical history, vital signs, and the results from clinical, laboratory and other safety assessments collected during the Screening period. For medical history, there must be an absence of clinically significant diagnosis (in the opinion of the Investigator) of cardiovascular, dermatologic, endocrine, gastrointestinal, infectious, hematologic, hepatic, immunologic, metabolic, oncologic, neurologic, psychiatric, renal, or respiratory disease that may increase the risk of the participant in this study

Exclusion Criteria

Participant has a history of herpes in the planned treatment site

Participant has, or the investigator believes them to have, a condition that would interfere with their ability to provide written informed consent, comply with study instructions, attend follow up visits, or which might confound the interpretation of the study results or put the subject at undue risk

Participants with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional, unacceptable risk to the participant or that could prevent, limit, or confound the protocol-specified assessments or study results' interpretation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a subcutaneous injection of Fractomer™ Biomatrix and are monitored for safety

6 weeks

Periodic in-person visits

Explant and Analysis

The implant is removed and examined for histological analysis

After the 6-week treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fractomer™ Biomatrix

Trial Overview The study tests the safety of Fractomer™ Biomatrix when implanted in humans. Volunteers receive a subcutaneous injection of this biomaterial, which aims to aid in soft tissue recovery.

How Is the Trial Designed?

Group I: Fractomer B Experimental Treatment 1 Intervention

Participants will be implanted with Fractomer B

Group II: Fractomer A Experimental Treatment 1 Intervention

Participants will be implanted with Fractomer A.

Who Is Running the Clinical Trial?

inSoma Bio, Inc.

Lead Sponsor

Citations

1. withpower.com withpower.com/trial/phase-subcutaneous-injection-7-2025-afaa0

Fractomer™ Biomatrix for Soft Tissue Injury This trial is for healthy volunteers willing to test a new medical device called Fractomer™ Biomatrix. It's designed to support soft tissue after an injury.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9592336/

Recombinant Elastin Biomatrix Improves Autologous Fat ... Our studies to date demonstrate that the Fractomer biomatrix can integrate with and increase the effective volume of adipose tissue, maximizing graft success.

3. ichgcp.net ichgcp.net/clinical-trials-registry/551170-first-in-human-safety-study-for-fractomer-biomatrix

Injectable Biomaterial Safety Study for Soft Tissue Repair The study focuses on evaluating the safety of an innovative injectable biomaterial called Fractomer™ Biomatrix in healthy human participants.

4. researchgate.net researchgate.net/publication/372681873_Recombinant_Elastin_Biomatrix_Improves_Autologous_Fat_Grafting_for_Soft_Tissue_Reconstruction

Recombinant Elastin Biomatrix Improves Autologous Fat ... Recombinant Elastin Biomatrix Improves Autologous Fat Grafting for Soft Tissue Reconstruction. October 2022. DOI:10.1097/01.GOX.0000898700.40391.61.

5. journals.lww.com journals.lww.com/prsgo/_layouts/15/oaks.journals/downloadpdf.aspx?an=01720096-202210001-00102

74 TRACK CONCLUSION: Our studies to date demonstrate that the. Fractomer biomatrix can integrate with and increase the effective volume of adipose tissue, maximizing ...

6. trial.medpath.com trial.medpath.com/clinical-trial/30fa70e6a7eef026/nct07151638-fractomer-biomatrix-safety-healthy-participants

First-in-Human Safety Study for Fractomer™ Biomatrix The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomer™ Biomatrix) in healthy volunteers.

7. insomabio.com insomabio.com/technology

Technology At room temperature, Fractomer looks and behaves like water. At body temperature, Fractomer rapidly forms a solid, porous scaffold.