Soft TissueNCT07151638
First-in-Human Safety Study for Fractomer™ Biomatrix
A study testing Implantation (injection) of a new biomatrix for soft tissue support. in people with Soft Tissue and Soft Tissue Defects, run by inSoma Bio, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomer™ Biomatrix) in healthy volunteers. The main question it aims to answer is: How do healthy volunteers react to this injectable implant? Participants will receive a subcutaneous injection of Fractomer and their health… Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue, Soft Tissue Defects, Subcutaneous Injection
- What is being tested?
- Implantation (injection) of a new biomatrix for soft tissue support.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to 22 Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 22 to 55.
- 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.
- 1. Participants with ongoing, stable anxiety and/or depression may be included, provided that they are stable and do not require the use of concomitant medications.
- 5. Ability to receive an injection of Fractomer™ and be willing to have a biopsy of the injection area be taken after either six weeks or three months.
Show all 9Show fewer
- 6. For a person of child-bearing potential (POCBP)2: participant has a negative urine pregnancy test and has agreed to use contraceptives3 prior to and during their clinical trial participation.
- 7. BMI of 24 to 39.9, inclusive.
- -
Who cannot join
- 1. 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.
- 2. 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.
- 3. Participant has or had a recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection defined by the presence of any of the following:
- History of recurrent infections (defined as ≥ 3 infections requiring antimicrobial therapy within the 12 months prior to Screening).
- Hospitalization for infection or receipt of a course of intravenous (IV) antimicrobial therapy within 8 weeks prior to screening OR an opportunistic infection requiring hospitalization or IV antimicrobial treatment within 1 year of screening.
- Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis) within 8 weeks prior to Screening.
Show all 22Show fewer
- Any herpes zoster, cytomegalovirus (CMV), or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to Screening.
- History of splenectomy.
- Participant has hepatitis B or C virus or liver disease.
- Participant has a known seropositivity for, or active human immunodeficiency virus (HIV) infection.
- Participant is undergoing chemotherapy or has a history of malignancy
- Participant has collagen or elastin-vascular disease or other auto-immune disease.
- Participant is on immunosuppressive therapy.
- Or other condition(s) as indicated by the Investigator. 4. Participant has a history of type 1 or type 2 diabetes. 5. Participant has an allergy to lidocaine or epinephrine. 6. Participant has a hypersensitivity or allergy to adhesive tape. 7. Participant is pregnant or lactating. 8. Participant has a history of allergy or hypersensitivity to collagen or elastin injections.
- 9. Participant is hypertensive (blood pressure 140/90 mmHg or higher), has cardiac or valvular disease, has a pacemaker or defibrillator, or has a known abdominal aortic aneurysm.
- 10. Participant has blood coagulopathy. 11. Participant has a pre-existing skin condition, such as eczema, psoriasis, allergic dermatitis, scarring, or other condition, occurring bilaterally within the planned treatment area.
- 12. Participant has a history of herpes in the planned treatment site. 13. Participant had radiation therapy or phototherapy, or current/active sunburn at the treatment site.
- 14. Participant has a history of hyper- or hypo-pigmentation. 15. Participant has a history of keloid formation or poor wound healing. 16. Participant is concurrently enrolled in clinical trial at the time of screening, or has had exposure to any investigational agent, including topical agents, within 30 days or 5 half-lives prior to their enrollment visit, whichever is longer.
- 17. Participant is an active, daily user of nicotine-containing products. 18. Participant is a user of recreational drugs as indicated by a positive result on drugs of abuse screen.
- If participant is user of THC products, participant may be included if they agree to stop use of THC products during their participation in this trial.
- If participant uses alcohol products, participant may be included if they limit their use to 2 or fewer alcohol units per day during their participation in this trial, and ingest no alcohol 48 hours before lab collection (site visit) timepoints.
- 19. Participants who are intoxicated at time of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Feasibility Trial for Fractomer™ Biomatrix: Safety Assessment in Healthy Human Participants
The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomer™ Biomatrix) in healthy volunteers. The main question it aims to answer is:
How do healthy volunteers react to this injectable implant?
Participants will receive a subcutaneous injection of Fractomer and their health will be monitored. After the monitoring period, the implant will be removed.
Read the detailed description
This clinical trial is designed to establish the safety of a new injectable device, which may provide a more effective means of treating deformations or voids in soft tissue. Healthy volunteers will be implanted in the subcutaneous space in the abdominal area, and health measures will be periodically recorded. The device will be removed per the protocol time periods, and the removed specimens will be examined for histological analysis by a trained pathologist. All data will be reviewed to determine the safety of this implanted, bioresorbable device.
- Conditions
- Soft Tissue, Soft Tissue Defects, Subcutaneous Injection
- Being tested
- Implantation (injection) of a new biomatrix for soft tissue support.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation (injection) of a new biomatrix for soft tissue support.Device
Also called Fractomer, implantable, bioresorbable medical device
Implantation of a new injectable medical device, Fractomer Biomatrix, to study the safety of the product in healthy human participants.
| Study group | Role | What they receive |
|---|---|---|
| Fractomer A | Experimental | Participants will be implanted with Fractomer A. Receives: Device: Implantation (injection) of a new biomatrix for soft tissue support. |
| Fractomer B | Experimental | Participants will be implanted with Fractomer B Receives: Device: Implantation (injection) of a new biomatrix for soft tissue support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with fever
Each participant's temperature and signs of fever will be measured at each in-person visit as a measure of potential systemic reaction to the implanted device.
Measured: Periodically over six weeks
Number of participants with abnormal blood chemistry measures
Participants will undergo blood draws at in-person visits to monitor serum chemistry. Any abnormal results that the investigator considers of concern will be flagged for follow-up. Each participant's blood chemistry will be measured at each in-person visit and evaluated as a measure of potential systemic reaction to the implanted device.
Measured: Periodically over six weeks
Number of participants with abnormal hematology results.
Participants will undergo blood draws at in-person visits to monitor hematology/CBC profile. Any abnormal results that the investigator considers of concern will be flagged for follow-up. Each participant's CBC profile will be measured at each in-person visit and evaluated as a measure of potential systemic reaction to the implanted device.
Measured: Periodically over six weeks
Number of participants with abnormal coagulation results.
Participants will undergo blood draws at in-person visits to monitor their coagulation profile. Any abnormal results that the investigator considers of concern will be flagged for follow-up. Each participant's coagulation profile will be measured at each in-person visit and evaluated as a measure of potential systemic reaction to the implanted device.
Measured: Periodically over six weeks
Number of participants with local signs of irritation or toxicity (observed at injection site)
Participants will be examined at each in-person visit for any redness, swelling, bruising, pain, or tenderness at the injection site.
Measured: Periodically over six weeks
Number of participants with subjective signs of systemic response.
Participants will undergo check-ins with investigators at in-person visits to monitor subjective signs of systemic reactions, including severe headaches or serious malaise. Any signs that the investigator considers of concern will be flagged for follow-up.
Measured: Periodically over six weeks
Number of participants with rejection or extrusion of the injection
Participants will undergo check-ins with investigators at in-person visits to monitor the injection site, including an examination for any evidence of rejection or extrusion of the implanted device.
Measured: Periodically over six weeks
Number of SAEs
Participants will undergo check-ins with investigators at in-person visits to monitor their health. Any SAE which is considered by the investigator to be injection- or device-related will be detailed and followed up per the protocol.
Measured: Periodically over six weeks
Secondary outcomes (1)
Participant cellular responses to implanted device.
Excised implants will be sent to expert pathologist assessment. The pathologist will note any observed peri-implant pathological response, including measures of inflammatory cell infiltrate, vascularization, fibrosis, notes on any residual implant, and the pathologist's overall conclusion on impact of the Fractomer™ implant.
Measured: After the six week explant timepoint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start11 Aug 2025
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Jan 2027 (estimated)
Why it stopped: Investigation into mild/moderate delayed reactions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- inSoma Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trisha Shamp, PhD, PA-C, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151638
- Sponsor's protocol ID
- FRA-001
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Trial for Fractomer™ Biomatrix: Safety Assessment in Healthy Human Participants
- ClinicalTrials.gov ID
- NCT07151638
- Acronym / sponsor ID
- FRA-001
- Conditions
- Soft Tissue, Soft Tissue Defects, Subcutaneous Injection
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Investigation into mild/moderate delayed reactions.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- inSoma Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomer™ Biomatrix) in healthy volunteers. The main question it aims to answer is:
How do healthy volunteers react to this injectable implant?
Participants will receive a subcutaneous injection of Fractomer and their health will be monitored. After the monitoring period, the implant will be removed.
Detailed description
This clinical trial is designed to establish the safety of a new injectable device, which may provide a more effective means of treating deformations or voids in soft tissue. Healthy volunteers will be implanted in the subcutaneous space in the abdominal area, and health measures will be periodically recorded. The device will be removed per the protocol time periods, and the removed specimens will be examined for histological analysis by a trained pathologist. All data will be reviewed to determine the safety of this implanted, bioresorbable device.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractomer A | Experimental | Device: Implantation (injection) of a new biomatrix for soft tissue support.Participants will be implanted with Fractomer A. |
| Fractomer B | Experimental | Device: Implantation (injection) of a new biomatrix for soft tissue support.Participants will be implanted with Fractomer B |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 22 to 55.
- 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.
- 1. Participants with ongoing, stable anxiety and/or depression may be included, provided that they are stable and do not require the use of concomitant medications.
Key exclusion criteria (22 listed)
- 1. 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.
- 2. 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.
- 3. Participant has or had a recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection defined by the presence of any of the following:
- 9. Participant is hypertensive (blood pressure 140/90 mmHg or higher), has cardiac or valvular disease, has a pacemaker or defibrillator, or has a known abdominal aortic aneurysm.
- 10. Participant has blood coagulopathy. 11. Participant has a pre-existing skin condition, such as eczema, psoriasis, allergic dermatitis, scarring, or other condition, occurring bilaterally within the planned treatment area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation (injection) of a new biomatrix for soft tissue support.Also: Fractomer, implantable, bioresorbable medical deviceImplantation of a new injectable medical device, Fractomer Biomatrix, to study the safety of the product in healthy human participants. | Device | Fractomer A, Fractomer B |
Primary outcome
Number of participants with fever
Time frame: Periodically over six weeks
Each participant's temperature and signs of fever will be measured at each in-person visit as a measure of potential systemic reaction to the implanted device.
Number of participants with abnormal blood chemistry measures
Time frame: Periodically over six weeks
Participants will undergo blood draws at in-person visits to monitor serum chemistry. Any abnormal results that the investigator considers of concern will be flagged for follow-up. Each participant's blood chemistry will be measured at each in-person visit and evaluated as a measure of potential systemic reaction to the implanted device.
Number of participants with abnormal hematology results.
Time frame: Periodically over six weeks
Participants will undergo blood draws at in-person visits to monitor hematology/CBC profile. Any abnormal results that the investigator considers of concern will be flagged for follow-up. Each participant's CBC profile will be measured at each in-person visit and evaluated as a measure of potential systemic reaction to the implanted device.
Number of participants with abnormal coagulation results.
Time frame: Periodically over six weeks
Participants will undergo blood draws at in-person visits to monitor their coagulation profile. Any abnormal results that the investigator considers of concern will be flagged for follow-up. Each participant's coagulation profile will be measured at each in-person visit and evaluated as a measure of potential systemic reaction to the implanted device.
Number of participants with local signs of irritation or toxicity (observed at injection site)
Time frame: Periodically over six weeks
Participants will be examined at each in-person visit for any redness, swelling, bruising, pain, or tenderness at the injection site.
Number of participants with subjective signs of systemic response.
Time frame: Periodically over six weeks
Participants will undergo check-ins with investigators at in-person visits to monitor subjective signs of systemic reactions, including severe headaches or serious malaise. Any signs that the investigator considers of concern will be flagged for follow-up.
Number of participants with rejection or extrusion of the injection
Time frame: Periodically over six weeks
Participants will undergo check-ins with investigators at in-person visits to monitor the injection site, including an examination for any evidence of rejection or extrusion of the implanted device.
Number of SAEs
Time frame: Periodically over six weeks
Participants will undergo check-ins with investigators at in-person visits to monitor their health. Any SAE which is considered by the investigator to be injection- or device-related will be detailed and followed up per the protocol.
1 secondary outcome
Participant cellular responses to implanted device.
Time frame: After the six week explant timepoint.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
Related trials for Soft Tissue
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
Not yet recruiting
Kinesitherapy Plus Osteopathy After Surgery for Dupuytren Disease
Dupuytren Disease
RecruitingPhase 1/2
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trisha Shamp, PhD, PA-C principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation (injection) of a new biomatrix for soft tissue support. in people with Soft Tissue and Soft Tissue Defects, run by inSoma Bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with fever (time frame: Periodically over six weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.