Clinical Trial

First-in-Human Safety Study for Fractomer™ Biomatrix

Suspended
View on ClinicalTrials.gov →
Why the trial stopped
Investigation into mild/moderate delayed reactions.
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 will be monitored. After the monitoring period, the implant will be removed.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-25; most recent amendment 2026-06-24.
Status change: Completed → Suspended 2026-06-24
Status change: Not Yet Recruiting → Completed 2025-12-16
Trial Details
NCT Number NCT07151638
Lead Sponsor inSoma Bio, Inc.
Conditions Soft Tissue, Soft Tissue Defects, Subcutaneous Injection
Enrollment 2 participants
Start Date 2025-08-11
Primary Completion 2026-12-22 (estimated)
Study Completion 2027-01-22 (estimated)
Updated on ClinicalTrials.gov 2026-06-26