NCT04890574

CellMist™ Autologous Cells to Treat Deep Second-Degree Burns

An Open Label Pilot Study to Evaluate the CellMist™ System in the Treatment of Deep Second Degree (IIoB) Burn Injuries With Autologous Skin Cells

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: RenovaCare, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this study is to evaluate the safety of the CellMist™ System in the treatment of deep second degree burns (II°B) in a prospective, multicenter, feasibility pilot study.

Detailed description

Patients between the ages of 18 and 65 years of age inclusive with a ≤ 30% Total Body Surface Area (TBSA) that requires surgical or enzymatic debridement and split thickness skin grafting (STSG) on any body surface excluding the face, joints, perineum and hands will be considered for participation in this study. CellMist™ solution (autologous epidermal and dermal cells) will be administered, via the System Skin Gun™, will be evenly distributed to aid in burn healing. Healing, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning safety of the CellMist™ System will be collected. Safety will be evaluated in terms of treatment and serious related adverse events. Each subject will participate in up to 9 total visits (screening, treatment and 7 follow-up study visits) over a period of 52 weeks. Up to 14 subjects will be enrolled and treated within this at up to 4 institutions.

Conditions

• Burns
• Burns Second Degree
• Burns Deep Second Degree

Interventions

Type	Name	Description
DEVICE	CellMist™ System	Open Label, Safety and Feasibility

Timeline

• Start date: 2021-05-26
• Primary completion: 2022-10-30
• Completion: 2022-11-30
• First posted: 2021-05-18
• Last updated: 2022-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study