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CellMist™ Autologous Cells to Treat Deep Second-Degree Burns — CELLMIST1  

Burns Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04890574
Study type Interventional
Source RenovaCare, Inc
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 26, 2021
Completion date November 30, 2022
View Details
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