NCT03826784

Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures

A Multicenter, Randomized, Controlled, Blinded Study of the Efficacy and Safety of Bone Healing Accelerant Versus Standard of Care in Subjects With Open Tibia Fractures

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Carmell Therapeutics Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open tibia fractures). It is hypothesized that by 6 months, the number of subjects with successful bone healing will be greater in the BHA-treated group compared to subjects treated with standard of care alone. Open tibia fractures were chosen for this study because healing rates are typically longer than for other bone fractures due to the limited vascular supply, limited soft tissue coverage, and higher risk of infection.

Conditions

• Tibial Fractures

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BHA	BHA active ingredients include a blood-derived component and beta-tricalcium phosphate. It is applied directly to the bone fracture and nearby viable bone at the time of wound closure.

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-01-01
• Completion: 2022-02-01
• First posted: 2019-02-01
• Last updated: 2020-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study